Regulatory Open Forum

Hello, 

I wanted to clarify MDSAP scope. Do sales, marketing, distribution fall under MDSAP scope? Is it just design, development and manufacturing, which I have seen on many certificates?  When a company first applies for the MDSAP, there is a questionnaire that all need to complete to get a quote; on the application, you will need to describe the scope for each applicable jurisdiction. 

What are the differences between scope and actual activities?  

Please help clarify. 

Thanks.

------------------------------
Karen Zhou
------------------------------

Dear Karen,
All activities you execute according to the roles you have as a market operator are part of a certification under the MDSAP. The scope is determined by the applicable sections of ISO 13485 taking into account provisions for exclusions that may be possible for some of the participating jurisdictions USA, AU, CDN, BR and Jp individually.
If you need help with MDSAP get in touch with us.
Best
Michael Maier - Senior Partner - Medidee Services
www.medidee.com



------------------------------
MichaelMaier
Senior Partner
Switzerland
michael.maier@medidee.com
------------------------------

Original Message:
Sent: 21-Aug-2019 19:17
From: Karen Zhou
Subject: Scope of MDSAP

Hello,

I wanted to clarify MDSAP scope. Do sales, marketing, distribution fall under MDSAP scope? Is it just design, development and manufacturing, which I have seen on many certificates?  When a company first applies for the MDSAP, there is a questionnaire that all need to complete to get a quote; on the application, you will need to describe the scope for each applicable jurisdiction.

What are the differences between scope and actual activities?

Please help clarify.

Thanks.

------------------------------
Karen Zhou
------------------------------

Karen,

From my own experience on scope statements with the QMS, the word marketing is usually not included.  But often see the term Sales.  And almost always see the term Distribution.  In simple answer yes - these activities, if performed and responsible for the organisation, should be listed in the scope statement.  So no, it is not just design, development, and manufacturing - I have seen many certificates that say: design, development, manufacturing, distribution, installation, and servicing.  I like to refer to the Health Canada guidance document on certificate scope statements (this was the guidance used for CMDCAS) as that has nice wording to use for scope statements in a QMS.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 22-Aug-2019 07:57
From: Michael Maier
Subject: Scope of MDSAP

Dear Karen,
All activities you execute according to the roles you have as a market operator are part of a certification under the MDSAP. The scope is determined by the applicable sections of ISO 13485 taking into account provisions for exclusions that may be possible for some of the participating jurisdictions USA, AU, CDN, BR and Jp individually.
If you need help with MDSAP get in touch with us.
Best
Michael Maier - Senior Partner - Medidee Services
www.medidee.com



------------------------------
MichaelMaier
Senior Partner
Switzerland
michael.maier@medidee.com

Original Message:
Sent: 21-Aug-2019 19:17
From: Karen Zhou
Subject: Scope of MDSAP

Hello,

I wanted to clarify MDSAP scope. Do sales, marketing, distribution fall under MDSAP scope? Is it just design, development and manufacturing, which I have seen on many certificates?  When a company first applies for the MDSAP, there is a questionnaire that all need to complete to get a quote; on the application, you will need to describe the scope for each applicable jurisdiction.

What are the differences between scope and actual activities?

Please help clarify.

Thanks.

------------------------------
Karen Zhou
------------------------------

Thanks Richard.  However, that's interesting because I have never seen sales in the scope statement. I did read the Health Canada guidance document on writing scope statements.  Sales and marketing are not within the scope of an ISO 13485 QMS, and neither do I see distribution (another term for sales) as being covered within the QMS.  The auditing organization I signed up with has a template for writing the scope statement and it ends with design, development and manufacture (installation and servicing).  I'd like some clarification on this.  Can a company still put the scope statement "design, development and manufacturing" even if they plan to do sales and marketing? 



------------------------------
Karen Zhou
------------------------------

Original Message:
Sent: 22-Aug-2019 16:04
From: Richard Vincins
Subject: Scope of MDSAP

Karen,

From my own experience on scope statements with the QMS, the word marketing is usually not included.  But often see the term Sales.  And almost always see the term Distribution.  In simple answer yes - these activities, if performed and responsible for the organisation, should be listed in the scope statement.  So no, it is not just design, development, and manufacturing - I have seen many certificates that say: design, development, manufacturing, distribution, installation, and servicing.  I like to refer to the Health Canada guidance document on certificate scope statements (this was the guidance used for CMDCAS) as that has nice wording to use for scope statements in a QMS.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 22-Aug-2019 07:57
From: Michael Maier
Subject: Scope of MDSAP

Dear Karen,
All activities you execute according to the roles you have as a market operator are part of a certification under the MDSAP. The scope is determined by the applicable sections of ISO 13485 taking into account provisions for exclusions that may be possible for some of the participating jurisdictions USA, AU, CDN, BR and Jp individually.
If you need help with MDSAP get in touch with us.
Best
Michael Maier - Senior Partner - Medidee Services
www.medidee.com



------------------------------
MichaelMaier
Senior Partner
Switzerland
michael.maier@medidee.com

Original Message:
Sent: 21-Aug-2019 19:17
From: Karen Zhou
Subject: Scope of MDSAP

Hello,

I wanted to clarify MDSAP scope. Do sales, marketing, distribution fall under MDSAP scope? Is it just design, development and manufacturing, which I have seen on many certificates?  When a company first applies for the MDSAP, there is a questionnaire that all need to complete to get a quote; on the application, you will need to describe the scope for each applicable jurisdiction.

What are the differences between scope and actual activities?

Please help clarify.

Thanks.

------------------------------
Karen Zhou
------------------------------

I would also be interested in having this better clarified. 

I think ISO 13485 still isn't part of MDSAP, correct?  And whether or not something falls within the scope of MDSAP would be determined by whether it falls within the scope of the QMS requirements of the different jurisdictions the MDSAP certificate will cover, correct?

Karen, if you could also clarify:

"Sales and marketing are not within the scope of an ISO 13485 QMS, and neither do I see distribution (another term for sales) as being covered within the QMS."

The second time you use QMS, are you still referring to ISO 13485?  If not, to which QMS are you referring?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 22-Aug-2019 16:17
From: Karen Zhou
Subject: Scope of MDSAP

Thanks Richard.  However, that's interesting because I have never seen sales in the scope statement. I did read the Health Canada guidance document on writing scope statements.  Sales and marketing are not within the scope of an ISO 13485 QMS, and neither do I see distribution (another term for sales) as being covered within the QMS.  The auditing organization I signed up with has a template for writing the scope statement and it ends with design, development and manufacture (installation and servicing).  I'd like some clarification on this.  Can a company still put the scope statement "design, development and manufacturing" even if they plan to do sales and marketing?



------------------------------
Karen Zhou

Original Message:
Sent: 22-Aug-2019 16:04
From: Richard Vincins
Subject: Scope of MDSAP

Karen,

From my own experience on scope statements with the QMS, the word marketing is usually not included.  But often see the term Sales.  And almost always see the term Distribution.  In simple answer yes - these activities, if performed and responsible for the organisation, should be listed in the scope statement.  So no, it is not just design, development, and manufacturing - I have seen many certificates that say: design, development, manufacturing, distribution, installation, and servicing.  I like to refer to the Health Canada guidance document on certificate scope statements (this was the guidance used for CMDCAS) as that has nice wording to use for scope statements in a QMS.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 22-Aug-2019 07:57
From: Michael Maier
Subject: Scope of MDSAP

Dear Karen,
All activities you execute according to the roles you have as a market operator are part of a certification under the MDSAP. The scope is determined by the applicable sections of ISO 13485 taking into account provisions for exclusions that may be possible for some of the participating jurisdictions USA, AU, CDN, BR and Jp individually.
If you need help with MDSAP get in touch with us.
Best
Michael Maier - Senior Partner - Medidee Services
www.medidee.com



------------------------------
MichaelMaier
Senior Partner
Switzerland
michael.maier@medidee.com

Original Message:
Sent: 21-Aug-2019 19:17
From: Karen Zhou
Subject: Scope of MDSAP

Hello,

I wanted to clarify MDSAP scope. Do sales, marketing, distribution fall under MDSAP scope? Is it just design, development and manufacturing, which I have seen on many certificates?  When a company first applies for the MDSAP, there is a questionnaire that all need to complete to get a quote; on the application, you will need to describe the scope for each applicable jurisdiction.

What are the differences between scope and actual activities?

Please help clarify.

Thanks.

------------------------------
Karen Zhou
------------------------------

Dear Julie;
MDSAP is an auditing program making use of ISO 13485 in its full extend. ISO 13485 requires that all applicable requirements are to be fulfilled - also any requirement applicable of any target market. MDSAP is putting those together and facilitating the auditing of the target market requirements of the countries beeing part of MDSAP under ISO 13485. MDSAP is not a management system standard - MDSAP is an audit program and an audit approach focussing on the logical links in a GMP=QMS=Management system.
I am available on Convergence, we can discuss this in more detail.
Best
Michael

------------------------------
Michael Maier
Senior Partner
Switzerland
michael.maier@medidee.com
------------------------------

Original Message:
Sent: 22-Aug-2019 17:39
From: Julie Omohundro
Subject: Scope of MDSAP

I would also be interested in having this better clarified.

I think ISO 13485 still isn't part of MDSAP, correct?  And whether or not something falls within the scope of MDSAP would be determined by whether it falls within the scope of the QMS requirements of the different jurisdictions the MDSAP certificate will cover, correct?

Karen, if you could also clarify:

"Sales and marketing are not within the scope of an ISO 13485 QMS, and neither do I see distribution (another term for sales) as being covered within the QMS."

The second time you use QMS, are you still referring to ISO 13485?  If not, to which QMS are you referring?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 22-Aug-2019 16:17
From: Karen Zhou
Subject: Scope of MDSAP

Thanks Richard.  However, that's interesting because I have never seen sales in the scope statement. I did read the Health Canada guidance document on writing scope statements.  Sales and marketing are not within the scope of an ISO 13485 QMS, and neither do I see distribution (another term for sales) as being covered within the QMS.  The auditing organization I signed up with has a template for writing the scope statement and it ends with design, development and manufacture (installation and servicing).  I'd like some clarification on this.  Can a company still put the scope statement "design, development and manufacturing" even if they plan to do sales and marketing?



------------------------------
Karen Zhou

Original Message:
Sent: 22-Aug-2019 16:04
From: Richard Vincins
Subject: Scope of MDSAP

Karen,

From my own experience on scope statements with the QMS, the word marketing is usually not included.  But often see the term Sales.  And almost always see the term Distribution.  In simple answer yes - these activities, if performed and responsible for the organisation, should be listed in the scope statement.  So no, it is not just design, development, and manufacturing - I have seen many certificates that say: design, development, manufacturing, distribution, installation, and servicing.  I like to refer to the Health Canada guidance document on certificate scope statements (this was the guidance used for CMDCAS) as that has nice wording to use for scope statements in a QMS.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 22-Aug-2019 07:57
From: Michael Maier
Subject: Scope of MDSAP

Dear Karen,
All activities you execute according to the roles you have as a market operator are part of a certification under the MDSAP. The scope is determined by the applicable sections of ISO 13485 taking into account provisions for exclusions that may be possible for some of the participating jurisdictions USA, AU, CDN, BR and Jp individually.
If you need help with MDSAP get in touch with us.
Best
Michael Maier - Senior Partner - Medidee Services
www.medidee.com



------------------------------
MichaelMaier
Senior Partner
Switzerland
michael.maier@medidee.com

Original Message:
Sent: 21-Aug-2019 19:17
From: Karen Zhou
Subject: Scope of MDSAP

Hello,

I wanted to clarify MDSAP scope. Do sales, marketing, distribution fall under MDSAP scope? Is it just design, development and manufacturing, which I have seen on many certificates?  When a company first applies for the MDSAP, there is a questionnaire that all need to complete to get a quote; on the application, you will need to describe the scope for each applicable jurisdiction.

What are the differences between scope and actual activities?

Please help clarify.

Thanks.

------------------------------
Karen Zhou
------------------------------

Julie,

ISO 13485:2016 is most certainly part of MDSAP.  Among other documents, the audit overview MDSAP AU P002.004 states:
Overview
The Medical Device Single Audit Program (MDSAP) audit process was designed and developed to ensure a single audit will provide efficient yet thorough coverage of the requirements of Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016), the Quality Management System requirements of the Conformity Assessment Procedures of the Australian Therapeutic Goods (Medical Devices) Regulations (TG(MD)R Sch3), Brazilian Good Manufacturing Practices (RDC ANVISA 16/2013), Japan Ordinance on Standards for Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostic Reagents (MHLW Ministerial Ordinance No. 169), the Quality System Regulation (21 CFR Part 820), and specific requirements of medical device regulatory authorities participating in the MDSAP program.

Hope this clarifies this issue.

James

------------------------------
James Bonds J.D.
Director Regulatory Affairs
Atlanta GA
United States
------------------------------

Original Message:
Sent: 22-Aug-2019 17:39
From: Julie Omohundro
Subject: Scope of MDSAP

I would also be interested in having this better clarified.

I think ISO 13485 still isn't part of MDSAP, correct?  And whether or not something falls within the scope of MDSAP would be determined by whether it falls within the scope of the QMS requirements of the different jurisdictions the MDSAP certificate will cover, correct?

Karen, if you could also clarify:

"Sales and marketing are not within the scope of an ISO 13485 QMS, and neither do I see distribution (another term for sales) as being covered within the QMS."

The second time you use QMS, are you still referring to ISO 13485?  If not, to which QMS are you referring?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 22-Aug-2019 16:17
From: Karen Zhou
Subject: Scope of MDSAP

Thanks Richard.  However, that's interesting because I have never seen sales in the scope statement. I did read the Health Canada guidance document on writing scope statements.  Sales and marketing are not within the scope of an ISO 13485 QMS, and neither do I see distribution (another term for sales) as being covered within the QMS.  The auditing organization I signed up with has a template for writing the scope statement and it ends with design, development and manufacture (installation and servicing).  I'd like some clarification on this.  Can a company still put the scope statement "design, development and manufacturing" even if they plan to do sales and marketing?



------------------------------
Karen Zhou

Original Message:
Sent: 22-Aug-2019 16:04
From: Richard Vincins
Subject: Scope of MDSAP

Karen,

From my own experience on scope statements with the QMS, the word marketing is usually not included.  But often see the term Sales.  And almost always see the term Distribution.  In simple answer yes - these activities, if performed and responsible for the organisation, should be listed in the scope statement.  So no, it is not just design, development, and manufacturing - I have seen many certificates that say: design, development, manufacturing, distribution, installation, and servicing.  I like to refer to the Health Canada guidance document on certificate scope statements (this was the guidance used for CMDCAS) as that has nice wording to use for scope statements in a QMS.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 22-Aug-2019 07:57
From: Michael Maier
Subject: Scope of MDSAP

Dear Karen,
All activities you execute according to the roles you have as a market operator are part of a certification under the MDSAP. The scope is determined by the applicable sections of ISO 13485 taking into account provisions for exclusions that may be possible for some of the participating jurisdictions USA, AU, CDN, BR and Jp individually.
If you need help with MDSAP get in touch with us.
Best
Michael Maier - Senior Partner - Medidee Services
www.medidee.com



------------------------------
MichaelMaier
Senior Partner
Switzerland
michael.maier@medidee.com

Original Message:
Sent: 21-Aug-2019 19:17
From: Karen Zhou
Subject: Scope of MDSAP

Hello,

I wanted to clarify MDSAP scope. Do sales, marketing, distribution fall under MDSAP scope? Is it just design, development and manufacturing, which I have seen on many certificates?  When a company first applies for the MDSAP, there is a questionnaire that all need to complete to get a quote; on the application, you will need to describe the scope for each applicable jurisdiction.

What are the differences between scope and actual activities?

Please help clarify.

Thanks.

------------------------------
Karen Zhou
------------------------------

So this is getting even more interesting.

Does this mean that a MDSAP certificate can now be used to support ISO 13485 certification, without need for a separate audit from the entity that issues ISO 13485 certificates.  Does another entity even need to issue an ISO 13485 certificate, or can a company claim ISO 13485 certification based on MDSAP certification?

Does this mean that, if ISO 13485 should have requirements that are not found in the QMS requirements of any of the regulatory jurisdictions covered in the audit, those additional requirements would have to be met also?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 22-Aug-2019 16:17
From: Karen Zhou
Subject: Scope of MDSAP

Thanks Richard.  However, that's interesting because I have never seen sales in the scope statement. I did read the Health Canada guidance document on writing scope statements.  Sales and marketing are not within the scope of an ISO 13485 QMS, and neither do I see distribution (another term for sales) as being covered within the QMS.  The auditing organization I signed up with has a template for writing the scope statement and it ends with design, development and manufacture (installation and servicing).  I'd like some clarification on this.  Can a company still put the scope statement "design, development and manufacturing" even if they plan to do sales and marketing?



------------------------------
Karen Zhou

Original Message:
Sent: 22-Aug-2019 16:04
From: Richard Vincins
Subject: Scope of MDSAP

Karen,

From my own experience on scope statements with the QMS, the word marketing is usually not included.  But often see the term Sales.  And almost always see the term Distribution.  In simple answer yes - these activities, if performed and responsible for the organisation, should be listed in the scope statement.  So no, it is not just design, development, and manufacturing - I have seen many certificates that say: design, development, manufacturing, distribution, installation, and servicing.  I like to refer to the Health Canada guidance document on certificate scope statements (this was the guidance used for CMDCAS) as that has nice wording to use for scope statements in a QMS.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 22-Aug-2019 07:57
From: Michael Maier
Subject: Scope of MDSAP

Dear Karen,
All activities you execute according to the roles you have as a market operator are part of a certification under the MDSAP. The scope is determined by the applicable sections of ISO 13485 taking into account provisions for exclusions that may be possible for some of the participating jurisdictions USA, AU, CDN, BR and Jp individually.
If you need help with MDSAP get in touch with us.
Best
Michael Maier - Senior Partner - Medidee Services
www.medidee.com



------------------------------
MichaelMaier
Senior Partner
Switzerland
michael.maier@medidee.com

Original Message:
Sent: 21-Aug-2019 19:17
From: Karen Zhou
Subject: Scope of MDSAP

Hello,

I wanted to clarify MDSAP scope. Do sales, marketing, distribution fall under MDSAP scope? Is it just design, development and manufacturing, which I have seen on many certificates?  When a company first applies for the MDSAP, there is a questionnaire that all need to complete to get a quote; on the application, you will need to describe the scope for each applicable jurisdiction.

What are the differences between scope and actual activities?

Please help clarify.

Thanks.

------------------------------
Karen Zhou
------------------------------

Dear Julie;
1) Yes
2) Yes
3) Yes
Before sb stands up and writes a scientific post about MDR or still MDD presumtion of conformity and importance of the ISO 13485 certificate - I am fully aware but this is just administrative phantom problems with no added value.
A CE certificate (MDD or MDR) is not linked to ISO 13485 certs, this is a private policy of some NBs to do so, No legal obligation. A NB that is sound will accept an ISO 13485 certificate delivered by a MDSAP AO for presumption of conformity to the requirements that are not specific MDD / MDR.
But the NB will anyway conduct an QMS audit against directive / regulation as part of the conformity assessment procedure, and there the NB will look into the aspects that are specific in ISO 13485 related to the presumption of conformity with the legal basis. In practice, those audits will anyway cover ISO 13485 in full...Be aware, MDR goes beyond the ISO 13485 in specific aspects.
Best
Michael 
www.medidee.com

------------------------------
MichaelMaier
Senior Partner
Switzerland
michael.maier@medidee.com
------------------------------

Original Message:
Sent: 23-Aug-2019 10:13
From: Julie Omohundro
Subject: Scope of MDSAP

So this is getting even more interesting.

Does this mean that a MDSAP certificate can now be used to support ISO 13485 certification, without need for a separate audit from the entity that issues ISO 13485 certificates.  Does another entity even need to issue an ISO 13485 certificate, or can a company claim ISO 13485 certification based on MDSAP certification?

Does this mean that, if ISO 13485 should have requirements that are not found in the QMS requirements of any of the regulatory jurisdictions covered in the audit, those additional requirements would have to be met also?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 22-Aug-2019 16:17
From: Karen Zhou
Subject: Scope of MDSAP

Thanks Richard.  However, that's interesting because I have never seen sales in the scope statement. I did read the Health Canada guidance document on writing scope statements.  Sales and marketing are not within the scope of an ISO 13485 QMS, and neither do I see distribution (another term for sales) as being covered within the QMS.  The auditing organization I signed up with has a template for writing the scope statement and it ends with design, development and manufacture (installation and servicing).  I'd like some clarification on this.  Can a company still put the scope statement "design, development and manufacturing" even if they plan to do sales and marketing?



------------------------------
Karen Zhou

Original Message:
Sent: 22-Aug-2019 16:04
From: Richard Vincins
Subject: Scope of MDSAP

Karen,

From my own experience on scope statements with the QMS, the word marketing is usually not included.  But often see the term Sales.  And almost always see the term Distribution.  In simple answer yes - these activities, if performed and responsible for the organisation, should be listed in the scope statement.  So no, it is not just design, development, and manufacturing - I have seen many certificates that say: design, development, manufacturing, distribution, installation, and servicing.  I like to refer to the Health Canada guidance document on certificate scope statements (this was the guidance used for CMDCAS) as that has nice wording to use for scope statements in a QMS.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 22-Aug-2019 07:57
From: Michael Maier
Subject: Scope of MDSAP

Dear Karen,
All activities you execute according to the roles you have as a market operator are part of a certification under the MDSAP. The scope is determined by the applicable sections of ISO 13485 taking into account provisions for exclusions that may be possible for some of the participating jurisdictions USA, AU, CDN, BR and Jp individually.
If you need help with MDSAP get in touch with us.
Best
Michael Maier - Senior Partner - Medidee Services
www.medidee.com



------------------------------
MichaelMaier
Senior Partner
Switzerland
michael.maier@medidee.com

Original Message:
Sent: 21-Aug-2019 19:17
From: Karen Zhou
Subject: Scope of MDSAP

Hello,

I wanted to clarify MDSAP scope. Do sales, marketing, distribution fall under MDSAP scope? Is it just design, development and manufacturing, which I have seen on many certificates?  When a company first applies for the MDSAP, there is a questionnaire that all need to complete to get a quote; on the application, you will need to describe the scope for each applicable jurisdiction.

What are the differences between scope and actual activities?

Please help clarify.

Thanks.

------------------------------
Karen Zhou
------------------------------

I seem to have taken this discussion off track by asking about ISO 13485.  Karen's request for clarification (Comment 4) on scope remains open.  Can someone provide the clarification she is asking for?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 22-Aug-2019 16:17
From: Karen Zhou
Subject: Scope of MDSAP

Thanks Richard.  However, that's interesting because I have never seen sales in the scope statement. I did read the Health Canada guidance document on writing scope statements.  Sales and marketing are not within the scope of an ISO 13485 QMS, and neither do I see distribution (another term for sales) as being covered within the QMS.  The auditing organization I signed up with has a template for writing the scope statement and it ends with design, development and manufacture (installation and servicing).  I'd like some clarification on this.  Can a company still put the scope statement "design, development and manufacturing" even if they plan to do sales and marketing?



------------------------------
Karen Zhou

Original Message:
Sent: 22-Aug-2019 16:04
From: Richard Vincins
Subject: Scope of MDSAP

Karen,

From my own experience on scope statements with the QMS, the word marketing is usually not included.  But often see the term Sales.  And almost always see the term Distribution.  In simple answer yes - these activities, if performed and responsible for the organisation, should be listed in the scope statement.  So no, it is not just design, development, and manufacturing - I have seen many certificates that say: design, development, manufacturing, distribution, installation, and servicing.  I like to refer to the Health Canada guidance document on certificate scope statements (this was the guidance used for CMDCAS) as that has nice wording to use for scope statements in a QMS.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 22-Aug-2019 07:57
From: Michael Maier
Subject: Scope of MDSAP

Dear Karen,
All activities you execute according to the roles you have as a market operator are part of a certification under the MDSAP. The scope is determined by the applicable sections of ISO 13485 taking into account provisions for exclusions that may be possible for some of the participating jurisdictions USA, AU, CDN, BR and Jp individually.
If you need help with MDSAP get in touch with us.
Best
Michael Maier - Senior Partner - Medidee Services
www.medidee.com



------------------------------
MichaelMaier
Senior Partner
Switzerland
michael.maier@medidee.com

Original Message:
Sent: 21-Aug-2019 19:17
From: Karen Zhou
Subject: Scope of MDSAP

Hello,

I wanted to clarify MDSAP scope. Do sales, marketing, distribution fall under MDSAP scope? Is it just design, development and manufacturing, which I have seen on many certificates?  When a company first applies for the MDSAP, there is a questionnaire that all need to complete to get a quote; on the application, you will need to describe the scope for each applicable jurisdiction.

What are the differences between scope and actual activities?

Please help clarify.

Thanks.

------------------------------
Karen Zhou
------------------------------

Karen,

If you plan to ever distribute product from your own facility, you have to add distribution in your scope. In all the companies I've done, the trio of: design and development, manufacturing, distribution -- is always used if the company does everything. Distribution includes activities performed by Sales and Marketing. Sales in terms of holding trunk stocks or coordinating the shipment of product. Marketing in terms of labeling of product, brochures, advertisements, etc. which are part of QMS oversight and in some cases, like the FDA and Health Canada, have to be submitted by Regulatory (depending on your product risk and classification).

Hope that helps,

------------------------------
Clarisa Tate
VP, Product Development and Regulatory Affairs
Medical Devices Professional, RA/QA/Engineering
Bay Area, CA
USA
------------------------------

Original Message:
Sent: 22-Aug-2019 16:17
From: Karen Zhou
Subject: Scope of MDSAP

Thanks Richard.  However, that's interesting because I have never seen sales in the scope statement. I did read the Health Canada guidance document on writing scope statements.  Sales and marketing are not within the scope of an ISO 13485 QMS, and neither do I see distribution (another term for sales) as being covered within the QMS.  The auditing organization I signed up with has a template for writing the scope statement and it ends with design, development and manufacture (installation and servicing).  I'd like some clarification on this.  Can a company still put the scope statement "design, development and manufacturing" even if they plan to do sales and marketing?



------------------------------
Karen Zhou

Original Message:
Sent: 22-Aug-2019 16:04
From: Richard Vincins
Subject: Scope of MDSAP

Karen,

From my own experience on scope statements with the QMS, the word marketing is usually not included.  But often see the term Sales.  And almost always see the term Distribution.  In simple answer yes - these activities, if performed and responsible for the organisation, should be listed in the scope statement.  So no, it is not just design, development, and manufacturing - I have seen many certificates that say: design, development, manufacturing, distribution, installation, and servicing.  I like to refer to the Health Canada guidance document on certificate scope statements (this was the guidance used for CMDCAS) as that has nice wording to use for scope statements in a QMS.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 22-Aug-2019 07:57
From: Michael Maier
Subject: Scope of MDSAP

Dear Karen,
All activities you execute according to the roles you have as a market operator are part of a certification under the MDSAP. The scope is determined by the applicable sections of ISO 13485 taking into account provisions for exclusions that may be possible for some of the participating jurisdictions USA, AU, CDN, BR and Jp individually.
If you need help with MDSAP get in touch with us.
Best
Michael Maier - Senior Partner - Medidee Services
www.medidee.com



------------------------------
MichaelMaier
Senior Partner
Switzerland
michael.maier@medidee.com

Original Message:
Sent: 21-Aug-2019 19:17
From: Karen Zhou
Subject: Scope of MDSAP

Hello,

I wanted to clarify MDSAP scope. Do sales, marketing, distribution fall under MDSAP scope? Is it just design, development and manufacturing, which I have seen on many certificates?  When a company first applies for the MDSAP, there is a questionnaire that all need to complete to get a quote; on the application, you will need to describe the scope for each applicable jurisdiction.

What are the differences between scope and actual activities?

Please help clarify.

Thanks.

------------------------------
Karen Zhou
------------------------------

Hi Karen,

In the MDSAP audit sequence, Device Marketing Authorization and Facility Registration, they look at conformity to requirements (and objective evidence) that the device can be sold in the MDSAP jurisdictions. Specifically the  MDSAP Audit Model states the following:
As a result of the audit of the Device Marketing Authorization and Facility Registration process, objective evidence will show whether the organization has:
A) Complied with requirements to register and/or license device facilities
B) Submitted device listing information to regulatory authorities when applicable
C) Obtained device marketing authorization in the appropriate jurisdictions
D) Arranged for assessment of changes (where applicable) and obtained marketing authorization
for changes to devices or the quality management system which require amendment to existing
marketing authorization

------------------------------
Stacie-Ann Creighton
Lebanon NJ
United States
------------------------------

Original Message:
Sent: 21-Aug-2019 19:17
From: Karen Zhou
Subject: Scope of MDSAP

Hello,

I wanted to clarify MDSAP scope. Do sales, marketing, distribution fall under MDSAP scope? Is it just design, development and manufacturing, which I have seen on many certificates?  When a company first applies for the MDSAP, there is a questionnaire that all need to complete to get a quote; on the application, you will need to describe the scope for each applicable jurisdiction.

What are the differences between scope and actual activities?

Please help clarify.

Thanks.

------------------------------
Karen Zhou
------------------------------

Since this thread has attracted some MDSAP experts, perhaps someone can direct me to the source of these statistics:

Close to 100% of Canadian manufacturers have MDSAP (no surprise there as it is required in Canada).  But also, of German manufacturers exporting to the US, around 40% have MDSAP.  Something under 5% of US domiciled manufacturers have MDSAP.

They were posted by Arthur Brandwood in another discussion here that, among other things, touched on transparency and credibility as they relate to MDSAP audits.  I asked him for the source, but by then it seems he had left the discussion.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 21-Aug-2019 19:17
From: Karen Zhou
Subject: Scope of MDSAP

Hello,

I wanted to clarify MDSAP scope. Do sales, marketing, distribution fall under MDSAP scope? Is it just design, development and manufacturing, which I have seen on many certificates?  When a company first applies for the MDSAP, there is a questionnaire that all need to complete to get a quote; on the application, you will need to describe the scope for each applicable jurisdiction.

What are the differences between scope and actual activities?

Please help clarify.

Thanks.

------------------------------
Karen Zhou
------------------------------

Last February Health Canada reported, "The MDSAP transition deadline of January 1st, 2019 has passed and Health Canada received over 3000 transition submissions or MDSAP certificates, representing just over 90% of medical device manufacturers. The Medical Devices Bureau (MDB) continues to process transition submissions and certificates."​  https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/international/transition-medical-device-single-audit-program.html

I haven't seen statistics for the others.

------------------------------
Anne LeBlanc
Manager, Regulatory Affairs
United States
------------------------------

Original Message:
Sent: 23-Aug-2019 14:57
From: Julie Omohundro
Subject: Scope of MDSAP

Since this thread has attracted some MDSAP experts, perhaps someone can direct me to the source of these statistics:

Close to 100% of Canadian manufacturers have MDSAP (no surprise there as it is required in Canada).  But also, of German manufacturers exporting to the US, around 40% have MDSAP.  Something under 5% of US domiciled manufacturers have MDSAP.

They were posted by Arthur Brandwood in another discussion here that, among other things, touched on transparency and credibility as they relate to MDSAP audits.  I asked him for the source, but by then it seems he had left the discussion.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 21-Aug-2019 19:17
From: Karen Zhou
Subject: Scope of MDSAP

Hello,

I wanted to clarify MDSAP scope. Do sales, marketing, distribution fall under MDSAP scope? Is it just design, development and manufacturing, which I have seen on many certificates?  When a company first applies for the MDSAP, there is a questionnaire that all need to complete to get a quote; on the application, you will need to describe the scope for each applicable jurisdiction.

What are the differences between scope and actual activities?

Please help clarify.

Thanks.

------------------------------
Karen Zhou
------------------------------

Julie,

FDA maintains the "official" MDSAP documents on its website. While MDSAP was put together by IMDRF it is now a separate program maintained by its own board. The EC and WHO are official observers but not participants in the program. And as others have stated ISO 13485:2016 is the basis for the audits conducted by the Auditing Organizations that are approved by the program.

The FDA website includes training materials which should be helpful to get official answers to your questions.

------------------------------
Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com
------------------------------

Original Message:
Sent: 23-Aug-2019 16:17
From: Anne LeBlanc
Subject: Scope of MDSAP

Last February Health Canada reported, "The MDSAP transition deadline of January 1st, 2019 has passed and Health Canada received over 3000 transition submissions or MDSAP certificates, representing just over 90% of medical device manufacturers. The Medical Devices Bureau (MDB) continues to process transition submissions and certificates."​  https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/international/transition-medical-device-single-audit-program.html

I haven't seen statistics for the others.

------------------------------
Anne LeBlanc
Manager, Regulatory Affairs
United States

Original Message:
Sent: 23-Aug-2019 14:57
From: Julie Omohundro
Subject: Scope of MDSAP

Since this thread has attracted some MDSAP experts, perhaps someone can direct me to the source of these statistics:

Close to 100% of Canadian manufacturers have MDSAP (no surprise there as it is required in Canada).  But also, of German manufacturers exporting to the US, around 40% have MDSAP.  Something under 5% of US domiciled manufacturers have MDSAP.

They were posted by Arthur Brandwood in another discussion here that, among other things, touched on transparency and credibility as they relate to MDSAP audits.  I asked him for the source, but by then it seems he had left the discussion.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 21-Aug-2019 19:17
From: Karen Zhou
Subject: Scope of MDSAP

Hello,

I wanted to clarify MDSAP scope. Do sales, marketing, distribution fall under MDSAP scope? Is it just design, development and manufacturing, which I have seen on many certificates?  When a company first applies for the MDSAP, there is a questionnaire that all need to complete to get a quote; on the application, you will need to describe the scope for each applicable jurisdiction.

What are the differences between scope and actual activities?

Please help clarify.

Thanks.

------------------------------
Karen Zhou
------------------------------

Edwin, while a good bit of early work on a MDSAP program was done by an IMDRF working group, enough changes seem to have been made to the program in the four years since this IMDRF work item was closed out, I'm not sure IMDRF can be credited with (or blamed for?) the program as it exists today.

While MDSAP may have separated from the IMDRF some time ago, today it does not appear to be a "separate" program in the sense of "freestanding," but a CDRH program.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com


Original Message:
Sent: 24-Aug-2019 07:49
From: Edwin Bills
Subject: Scope of MDSAP

Julie,

FDA maintains the "official" MDSAP documents on its website. While MDSAP was put together by IMDRF it is now a separate program maintained by its own board. The EC and WHO are official observers but not participants in the program. And as others have stated ISO 13485:2016 is the basis for the audits conducted by the Auditing Organizations that are approved by the program.

The FDA website includes training materials which should be helpful to get official answers to your questions.

------------------------------
Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com

Original Message:
Sent: 23-Aug-2019 16:17
From: Anne LeBlanc
Subject: Scope of MDSAP

Last February Health Canada reported, "The MDSAP transition deadline of January 1st, 2019 has passed and Health Canada received over 3000 transition submissions or MDSAP certificates, representing just over 90% of medical device manufacturers. The Medical Devices Bureau (MDB) continues to process transition submissions and certificates."​  https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/international/transition-medical-device-single-audit-program.html

I haven't seen statistics for the others.

------------------------------
Anne LeBlanc
Manager, Regulatory Affairs
United States

Original Message:
Sent: 23-Aug-2019 14:57
From: Julie Omohundro
Subject: Scope of MDSAP

Since this thread has attracted some MDSAP experts, perhaps someone can direct me to the source of these statistics:

Close to 100% of Canadian manufacturers have MDSAP (no surprise there as it is required in Canada).  But also, of German manufacturers exporting to the US, around 40% have MDSAP.  Something under 5% of US domiciled manufacturers have MDSAP.

They were posted by Arthur Brandwood in another discussion here that, among other things, touched on transparency and credibility as they relate to MDSAP audits.  I asked him for the source, but by then it seems he had left the discussion.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 21-Aug-2019 19:17
From: Karen Zhou
Subject: Scope of MDSAP

Hello,

I wanted to clarify MDSAP scope. Do sales, marketing, distribution fall under MDSAP scope? Is it just design, development and manufacturing, which I have seen on many certificates?  When a company first applies for the MDSAP, there is a questionnaire that all need to complete to get a quote; on the application, you will need to describe the scope for each applicable jurisdiction.

What are the differences between scope and actual activities?

Please help clarify.

Thanks.

------------------------------
Karen Zhou
------------------------------

Julie, not a CDRH program, but one which was developed by IMDRF and is now in implementation under a Regulatory Authority Council drawn from all of the participating authorities, of which FDA is one.

------------------------------
Arthur Brandwood PhD FRAPS
Director and Principal Consultant
Brandwood CKC
Sydney, Australia
Arthur.brandwood@brandwoodckc.com
------------------------------

Original Message:
Sent: 24-Aug-2019 13:14
From: Julie Omohundro
Subject: Scope of MDSAP

Edwin, while a good bit of early work on a MDSAP program was done by an IMDRF working group, enough changes seem to have been made to the program in the four years since this IMDRF work item was closed out, I'm not sure IMDRF can be credited with (or blamed for?) the program as it exists today.

While MDSAP may have separated from the IMDRF some time ago, today it does not appear to be a "separate" program in the sense of "freestanding," but a CDRH program.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com


Original Message:
Sent: 24-Aug-2019 07:49
From: Edwin Bills
Subject: Scope of MDSAP

Julie,

FDA maintains the "official" MDSAP documents on its website. While MDSAP was put together by IMDRF it is now a separate program maintained by its own board. The EC and WHO are official observers but not participants in the program. And as others have stated ISO 13485:2016 is the basis for the audits conducted by the Auditing Organizations that are approved by the program.

The FDA website includes training materials which should be helpful to get official answers to your questions.

------------------------------
Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com

Original Message:
Sent: 23-Aug-2019 16:17
From: Anne LeBlanc
Subject: Scope of MDSAP

Last February Health Canada reported, "The MDSAP transition deadline of January 1st, 2019 has passed and Health Canada received over 3000 transition submissions or MDSAP certificates, representing just over 90% of medical device manufacturers. The Medical Devices Bureau (MDB) continues to process transition submissions and certificates."​  https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/international/transition-medical-device-single-audit-program.html

I haven't seen statistics for the others.

------------------------------
Anne LeBlanc
Manager, Regulatory Affairs
United States

Original Message:
Sent: 23-Aug-2019 14:57
From: Julie Omohundro
Subject: Scope of MDSAP

Since this thread has attracted some MDSAP experts, perhaps someone can direct me to the source of these statistics:

Close to 100% of Canadian manufacturers have MDSAP (no surprise there as it is required in Canada).  But also, of German manufacturers exporting to the US, around 40% have MDSAP.  Something under 5% of US domiciled manufacturers have MDSAP.

They were posted by Arthur Brandwood in another discussion here that, among other things, touched on transparency and credibility as they relate to MDSAP audits.  I asked him for the source, but by then it seems he had left the discussion.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 21-Aug-2019 19:17
From: Karen Zhou
Subject: Scope of MDSAP

Hello,

I wanted to clarify MDSAP scope. Do sales, marketing, distribution fall under MDSAP scope? Is it just design, development and manufacturing, which I have seen on many certificates?  When a company first applies for the MDSAP, there is a questionnaire that all need to complete to get a quote; on the application, you will need to describe the scope for each applicable jurisdiction.

What are the differences between scope and actual activities?

Please help clarify.

Thanks.

------------------------------
Karen Zhou
------------------------------

Thanks, Anne.  I was aware that HC had MDSAP information posted somewhere. I appreciate the link.  I assume it means "...just over 90% of medical device manufacturers that market medical devices in Canada."

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 23-Aug-2019 16:17
From: Anne LeBlanc
Subject: Scope of MDSAP

Last February Health Canada reported, "The MDSAP transition deadline of January 1st, 2019 has passed and Health Canada received over 3000 transition submissions or MDSAP certificates, representing just over 90% of medical device manufacturers. The Medical Devices Bureau (MDB) continues to process transition submissions and certificates."​  https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/international/transition-medical-device-single-audit-program.html

I haven't seen statistics for the others.

------------------------------
Anne LeBlanc
Manager, Regulatory Affairs
United States

Original Message:
Sent: 23-Aug-2019 14:57
From: Julie Omohundro
Subject: Scope of MDSAP

Since this thread has attracted some MDSAP experts, perhaps someone can direct me to the source of these statistics:

Close to 100% of Canadian manufacturers have MDSAP (no surprise there as it is required in Canada).  But also, of German manufacturers exporting to the US, around 40% have MDSAP.  Something under 5% of US domiciled manufacturers have MDSAP.

They were posted by Arthur Brandwood in another discussion here that, among other things, touched on transparency and credibility as they relate to MDSAP audits.  I asked him for the source, but by then it seems he had left the discussion.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 21-Aug-2019 19:17
From: Karen Zhou
Subject: Scope of MDSAP

Hello,

I wanted to clarify MDSAP scope. Do sales, marketing, distribution fall under MDSAP scope? Is it just design, development and manufacturing, which I have seen on many certificates?  When a company first applies for the MDSAP, there is a questionnaire that all need to complete to get a quote; on the application, you will need to describe the scope for each applicable jurisdiction.

What are the differences between scope and actual activities?

Please help clarify.

Thanks.

------------------------------
Karen Zhou
------------------------------

Julie - apologies for not coming back to you.  The source is yours truly.  They are an approximate estimate based on deriving the number of manufacturers importing to the US by country of domicile (this can be extracted from FDA registration database) and the number of manufacturers in each of those countries who had obtained MDSAP certification.

Now the numbers are at least a year old - with MDSAP uptake growing rapidly, and there is some lack of overlap (not all those MDSAP certified companies will be exporters to the US).  but they were an approximate guide to the relative uptake.

Arthur

------------------------------
Arthur Brandwood PhD FRAPS
Director and Principal Consultant
Brandwood CKC
Sydney, Australia
Arthur.brandwood@brandwoodckc.com
------------------------------

Original Message:
Sent: 23-Aug-2019 14:57
From: Julie Omohundro
Subject: Scope of MDSAP

Since this thread has attracted some MDSAP experts, perhaps someone can direct me to the source of these statistics:

Close to 100% of Canadian manufacturers have MDSAP (no surprise there as it is required in Canada).  But also, of German manufacturers exporting to the US, around 40% have MDSAP.  Something under 5% of US domiciled manufacturers have MDSAP.

They were posted by Arthur Brandwood in another discussion here that, among other things, touched on transparency and credibility as they relate to MDSAP audits.  I asked him for the source, but by then it seems he had left the discussion.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 21-Aug-2019 19:17
From: Karen Zhou
Subject: Scope of MDSAP

Hello,

I wanted to clarify MDSAP scope. Do sales, marketing, distribution fall under MDSAP scope? Is it just design, development and manufacturing, which I have seen on many certificates?  When a company first applies for the MDSAP, there is a questionnaire that all need to complete to get a quote; on the application, you will need to describe the scope for each applicable jurisdiction.

What are the differences between scope and actual activities?

Please help clarify.

Thanks.

------------------------------
Karen Zhou
------------------------------

Arthur, thanks for the additional info.

What is your source for the number of manufacturers who have obtained MDSAP certification?  I don't think this information is available in the FDA database?



------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 27-Aug-2019 02:57
From: Arthur Brandwood
Subject: Scope of MDSAP

Julie - apologies for not coming back to you.  The source is yours truly.  They are an approximate estimate based on deriving the number of manufacturers importing to the US by country of domicile (this can be extracted from FDA registration database) and the number of manufacturers in each of those countries who had obtained MDSAP certification.

Now the numbers are at least a year old - with MDSAP uptake growing rapidly, and there is some lack of overlap (not all those MDSAP certified companies will be exporters to the US).  but they were an approximate guide to the relative uptake.

Arthur

------------------------------
Arthur Brandwood PhD FRAPS
Director and Principal Consultant
Brandwood CKC
Sydney, Australia
Arthur.brandwood@brandwoodckc.com

Original Message:
Sent: 23-Aug-2019 14:57
From: Julie Omohundro
Subject: Scope of MDSAP

Since this thread has attracted some MDSAP experts, perhaps someone can direct me to the source of these statistics:

Close to 100% of Canadian manufacturers have MDSAP (no surprise there as it is required in Canada).  But also, of German manufacturers exporting to the US, around 40% have MDSAP.  Something under 5% of US domiciled manufacturers have MDSAP.

They were posted by Arthur Brandwood in another discussion here that, among other things, touched on transparency and credibility as they relate to MDSAP audits.  I asked him for the source, but by then it seems he had left the discussion.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 21-Aug-2019 19:17
From: Karen Zhou
Subject: Scope of MDSAP

Hello,

I wanted to clarify MDSAP scope. Do sales, marketing, distribution fall under MDSAP scope? Is it just design, development and manufacturing, which I have seen on many certificates?  When a company first applies for the MDSAP, there is a questionnaire that all need to complete to get a quote; on the application, you will need to describe the scope for each applicable jurisdiction.

What are the differences between scope and actual activities?

Please help clarify.

Thanks.

------------------------------
Karen Zhou
------------------------------

Original Message------

Arthur, thanks for the additional info.

What is your source for the number of manufacturers who have obtained MDSAP certification?  I don't think this information is available in the FDA database?



------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Thanks, Michael!

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 27-Aug-2019 10:13
From: Michael Maier
Subject: Scope of MDSAP

Hi Julie, i will get that for you once back in the office, no problem.

Best

Michael

Holen Sie sich Outlook für Android

Original Message------

Arthur, thanks for the additional info.

What is your source for the number of manufacturers who have obtained MDSAP certification?  I don't think this information is available in the FDA database?



------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Just to further confuse things, IMDRF through its Good Regulatory Review Practices (GRRP) working group (WG), is working on a new guidance for a the collection of final documents to create a program, tentatively dubbed the Medical Device Single Review Program, with the CDRH director leading efforts for regulators to rely in whole or in part on each other's decisions.  This was posted on Regulatory Focus under title of IMDRF Drafts Requirements for Recognition of Conformity Assessment Bodies .   There is a consultation on a new draft document which closes on October 3.  Looks like not only will they move towards single audits discussed on this thread, but also since device clearances.




------------------------------
Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com
------------------------------

Original Message:
Sent: 27-Aug-2019 13:35
From: Julie Omohundro
Subject: Scope of MDSAP

Thanks, Michael!

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 27-Aug-2019 10:13
From: Michael Maier
Subject: Scope of MDSAP

Hi Julie, i will get that for you once back in the office, no problem.

Best

Michael

Holen Sie sich Outlook für Android

Original Message------

Arthur, thanks for the additional info.

What is your source for the number of manufacturers who have obtained MDSAP certification?  I don't think this information is available in the FDA database?



------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Ah, well, that's why I got into regulatory, for the confusion.  And it has never disappointed me. :)

Something amiss here?
"...but also since device clearances."

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 28-Aug-2019 11:20
From: Edwin Bills
Subject: Scope of MDSAP

Just to further confuse things, IMDRF through its Good Regulatory Review Practices (GRRP) working group (WG), is working on a new guidance for a the collection of final documents to create a program, tentatively dubbed the Medical Device Single Review Program, with the CDRH director leading efforts for regulators to rely in whole or in part on each other's decisions.  This was posted on Regulatory Focus under title of IMDRF Drafts Requirements for Recognition of Conformity Assessment Bodies .   There is a consultation on a new draft document which closes on October 3.  Looks like not only will they move towards single audits discussed on this thread, but also since device clearances.




------------------------------
Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com

Original Message:
Sent: 27-Aug-2019 13:35
From: Julie Omohundro
Subject: Scope of MDSAP

Thanks, Michael!

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 27-Aug-2019 10:13
From: Michael Maier
Subject: Scope of MDSAP

Hi Julie, i will get that for you once back in the office, no problem.

Best

Michael

Holen Sie sich Outlook für Android

Original Message------

Arthur, thanks for the additional info.

What is your source for the number of manufacturers who have obtained MDSAP certification?  I don't think this information is available in the FDA database?



------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Michael, does this mean you have a source for this information separate from Arthur's?  If so I'd still like to know...

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 27-Aug-2019 10:13
From: Michael Maier
Subject: Scope of MDSAP

Hi Julie, i will get that for you once back in the office, no problem.

Best

Michael

Holen Sie sich Outlook für Android

Original Message------

Arthur, thanks for the additional info.

What is your source for the number of manufacturers who have obtained MDSAP certification?  I don't think this information is available in the FDA database?



------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Julie the numbers came from an MDSAP update presentation I saw in a conference slide about a 18 months ago.  these numbers pop up from time to time in update presentations.  But I am darned if I can locate the data now.

This gives a summary of overall uptake to 2018 - but not broken down by country...  From a presentation at https://www.fda.gov/media/123484/download


------------------------------
Arthur Brandwood PhD FRAPS
Director and Principal Consultant
Brandwood CKC
Sydney, Australia
Arthur.brandwood@brandwoodckc.com
------------------------------

Original Message:
Sent: 27-Aug-2019 09:10
From: Julie Omohundro
Subject: Scope of MDSAP

Arthur, thanks for the additional info.

What is your source for the number of manufacturers who have obtained MDSAP certification?  I don't think this information is available in the FDA database?



------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 27-Aug-2019 02:57
From: Arthur Brandwood
Subject: Scope of MDSAP

Julie - apologies for not coming back to you.  The source is yours truly.  They are an approximate estimate based on deriving the number of manufacturers importing to the US by country of domicile (this can be extracted from FDA registration database) and the number of manufacturers in each of those countries who had obtained MDSAP certification.

Now the numbers are at least a year old - with MDSAP uptake growing rapidly, and there is some lack of overlap (not all those MDSAP certified companies will be exporters to the US).  but they were an approximate guide to the relative uptake.

Arthur

------------------------------
Arthur Brandwood PhD FRAPS
Director and Principal Consultant
Brandwood CKC
Sydney, Australia
Arthur.brandwood@brandwoodckc.com

Original Message:
Sent: 23-Aug-2019 14:57
From: Julie Omohundro
Subject: Scope of MDSAP

Since this thread has attracted some MDSAP experts, perhaps someone can direct me to the source of these statistics:

Close to 100% of Canadian manufacturers have MDSAP (no surprise there as it is required in Canada).  But also, of German manufacturers exporting to the US, around 40% have MDSAP.  Something under 5% of US domiciled manufacturers have MDSAP.

They were posted by Arthur Brandwood in another discussion here that, among other things, touched on transparency and credibility as they relate to MDSAP audits.  I asked him for the source, but by then it seems he had left the discussion.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 21-Aug-2019 19:17
From: Karen Zhou
Subject: Scope of MDSAP

Hello,

I wanted to clarify MDSAP scope. Do sales, marketing, distribution fall under MDSAP scope? Is it just design, development and manufacturing, which I have seen on many certificates?  When a company first applies for the MDSAP, there is a questionnaire that all need to complete to get a quote; on the application, you will need to describe the scope for each applicable jurisdiction.

What are the differences between scope and actual activities?

Please help clarify.

Thanks.

------------------------------
Karen Zhou
------------------------------

Julie,  for further background on MDSAP - see this set of posts on our website.   (In reverse chronological order)

https://brandwoodckc.com/japan-renews-its-participation-in-mdsap-until-2020/
https://brandwoodckc.com/mdsap-stakeholder-update-fda-tga-health-canada-pmda-anvisa/
https://brandwoodckc.com/mdsap-recap/

We also have a training webinar (slide set and video at http://bit.ly/MDSAP-webinar)

Arthur

------------------------------
Arthur Brandwood PhD FRAPS
Director and Principal Consultant
Brandwood CKC
Sydney, Australia
Arthur.brandwood@brandwoodckc.com
------------------------------

Thanks, Arthur.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 27-Aug-2019 21:17
From: Arthur Brandwood
Subject: Scope of MDSAP

Julie the numbers came from an MDSAP update presentation I saw in a conference slide about a 18 months ago.  these numbers pop up from time to time in update presentations.  But I am darned if I can locate the data now.

This gives a summary of overall uptake to 2018 - but not broken down by country...  From a presentation at https://www.fda.gov/media/123484/download

------------------------------
Arthur Brandwood PhD FRAPS
Director and Principal Consultant
Brandwood CKC
Sydney, Australia
Arthur.brandwood@brandwoodckc.com

Original Message:
Sent: 27-Aug-2019 09:10
From: Julie Omohundro
Subject: Scope of MDSAP

Arthur, thanks for the additional info.

What is your source for the number of manufacturers who have obtained MDSAP certification?  I don't think this information is available in the FDA database?



------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 27-Aug-2019 02:57
From: Arthur Brandwood
Subject: Scope of MDSAP

Julie - apologies for not coming back to you.  The source is yours truly.  They are an approximate estimate based on deriving the number of manufacturers importing to the US by country of domicile (this can be extracted from FDA registration database) and the number of manufacturers in each of those countries who had obtained MDSAP certification.

Now the numbers are at least a year old - with MDSAP uptake growing rapidly, and there is some lack of overlap (not all those MDSAP certified companies will be exporters to the US).  but they were an approximate guide to the relative uptake.

Arthur

------------------------------
Arthur Brandwood PhD FRAPS
Director and Principal Consultant
Brandwood CKC
Sydney, Australia
Arthur.brandwood@brandwoodckc.com

Original Message:
Sent: 23-Aug-2019 14:57
From: Julie Omohundro
Subject: Scope of MDSAP

Since this thread has attracted some MDSAP experts, perhaps someone can direct me to the source of these statistics:

Close to 100% of Canadian manufacturers have MDSAP (no surprise there as it is required in Canada).  But also, of German manufacturers exporting to the US, around 40% have MDSAP.  Something under 5% of US domiciled manufacturers have MDSAP.

They were posted by Arthur Brandwood in another discussion here that, among other things, touched on transparency and credibility as they relate to MDSAP audits.  I asked him for the source, but by then it seems he had left the discussion.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 21-Aug-2019 19:17
From: Karen Zhou
Subject: Scope of MDSAP

Hello,

I wanted to clarify MDSAP scope. Do sales, marketing, distribution fall under MDSAP scope? Is it just design, development and manufacturing, which I have seen on many certificates?  When a company first applies for the MDSAP, there is a questionnaire that all need to complete to get a quote; on the application, you will need to describe the scope for each applicable jurisdiction.

What are the differences between scope and actual activities?

Please help clarify.

Thanks.

------------------------------
Karen Zhou
------------------------------