Regulatory Open Forum

Robert Schiff said, "The only official document in the United States is 21 CFR 820, the quality system regulation.  As you point out there's a lot of talk about 13485.  This is not a recognized standard in the United States."

This needs a little clarification.

In medical devices, as in other areas, there are national standards and standards recognized by the regulatory agency.

In the US, the national standard is ANSI/AAMI/ISO 13485:2016, based on the international standard ISO 13485:2016.

The US regulatory agency, FDA, doesn't list either the US national standard nor the international standard as a recognized consensus standard.

The proposal is included in the Spring 2019 Unified Agenda which says, "FDA intends to harmonize and modernize the Quality System regulation for medical devices. The revisions will supplant the existing requirements with the specifications of an international consensus standard for medical device manufacture, ISO 13485:2016. The revisions are intended to reduce compliance and recordkeeping burdens on device manufacturers by harmonizing domestic and international requirements. The revisions will also modernize the regulation."

Note that the revisions will "supplant" the existing requirements. Merriam-Webster provides multiple definitions, but the applicable one is probably, "to take the place of and serve as a substitute for especially by reason of superior excellence or power".

A RAPS article from Oct. 22, 2018 says, "CDRH, meanwhile, intends to roll out its revised quality system regulation by April 2019. In an attempt to ease the concerned faces among audience members, Maisel stressed that there will be a public comment period after each step in the process to adopt the rule proposed in May."

Robert Schiff said, "The only official document in the United States is 21 CFR 820, the quality system regulation.  As you point out there's a lot of talk about 13485.  This is not a recognized standard in the United States."

This needs a little clarification.

In medical devices, as in other areas, there are national standards and standards recognized by the regulatory agency.

In the US, the national standard is ANSI/AAMI/ISO 13485:2016, based on the international standard ISO 13485:2016.

The US regulatory agency, FDA, doesn't list either the US national standard nor the international standard as a recognized consensus standard.

The proposal is included in the Spring 2019 Unified Agenda which says, "FDA intends to harmonize and modernize the Quality System regulation for medical devices. The revisions will supplant the existing requirements with the specifications of an international consensus standard for medical device manufacture, ISO 13485:2016. The revisions are intended to reduce compliance and recordkeeping burdens on device manufacturers by harmonizing domestic and international requirements. The revisions will also modernize the regulation."

Note that the revisions will "supplant" the existing requirements. Merriam-Webster provides multiple definitions, but the applicable one is probably, "to take the place of and serve as a substitute for especially by reason of superior excellence or power".

A RAPS article from Oct. 22, 2018 says, "CDRH, meanwhile, intends to roll out its revised quality system regulation by April 2019. In an attempt to ease the concerned faces among audience members, Maisel stressed that there will be a public comment period after each step in the process to adopt the rule proposed in May."

Robert Schiff said, "The only official document in the United States is 21 CFR 820, the quality system regulation.  As you point out there's a lot of talk about 13485.  This is not a recognized standard in the United States."

This needs a little clarification.

In medical devices, as in other areas, there are national standards and standards recognized by the regulatory agency.

In the US, the national standard is ANSI/AAMI/ISO 13485:2016, based on the international standard ISO 13485:2016.

The US regulatory agency, FDA, doesn't list either the US national standard nor the international standard as a recognized consensus standard.

ECM – Medical Device Certification
ECM Israel – Medical Devices Certification

When I try to follow the LI link to their websites, McAfee tell me to "Whoa!"  ECM Israel's listing describes it as an "Italian Notified Body providing efficient and high quality Certification and Testing Services."

There is also a Company named "Ente Certificazione Macchine."  When I click on the LI link to its website, McAfee stays quiet, so I was able to learn that it is "an ISO 17065 Notified Body (1282) and as an accredited ISO 17025 Testing Lab (1515 L)."  All three companies post the same logo.

This could all be due to some of the many glitches in LI's software, a complicated corporate NB structure, and/or perhaps a marketing team that doesn't know much about FDA regulation of medical devices.

I did a little googling and found this news release about ECM America:

https://www.healthcaredive.com/press-release/20180829-ecm-america-mdd-notified-body-launches-us-dedicated-website-ecmamericaco/

It uses the same logo also.  The announcement states that it also offers ISO 13485 certification, and thereby stands to benefit financially if medical device manufacturers think they must have ISO 13485 to market medical devices in the US.   The announcement doesn't indicate that it has been designated under either MDD or MDR.  When I try to go to its website (https://ecmamerica.com/), McAfee tells me to whoa again.

Anyway, enough time spent on something of limited interest to me.  Maybe you guys might want to investigate further.

ECM – Medical Device Certification
ECM Israel – Medical Devices Certification

When I try to follow the LI link to their websites, McAfee tell me to "Whoa!"  ECM Israel's listing describes it as an "Italian Notified Body providing efficient and high quality Certification and Testing Services."

There is also a Company named "Ente Certificazione Macchine."  When I click on the LI link to its website, McAfee stays quiet, so I was able to learn that it is "an ISO 17065 Notified Body (1282) and an accredited ISO 17025 Testing Lab (1515 L)."  All three companies post the same logo.

This could all be due to some of the many glitches in LI's software, a complicated corporate NB structure, and/or perhaps a marketing team that doesn't know much about FDA regulation of medical devices.

It has also occurred to me that the EU situation seems ripe for NB-related scams, including the spoofing of legitimate NBs and the creation of fake NBs.  It's clear from posts in the Forum and on LinkedIn that there are plenty of device companies out there that haven't been paying attention, and that are becoming frantic when they realize that the NB ship may have sailed.  A device company that is only just waking up to the realities in the EU seems like an easy target for a scam.

I did a little googling and found this news release about ECM America:

https://www.healthcaredive.com/press-release/20180829-ecm-america-mdd-notified-body-launches-us-dedicated-website-ecmamericaco/

It uses the same logo also.  The announcement states that it also offers ISO 13485 certification, and thereby stands to benefit financially if medical device manufacturers think they must have ISO 13485 to market medical devices in the US.   The announcement doesn't indicate that it has been designated under either MDD or MDR.  When I try to go to its website (https://ecmamerica.com/), McAfee tells me to whoa again.

Anyway, enough time spent on something that, however fascinating, is not a current priority for me.  Maybe one of you guys might want to investigate further....

ECM – Medical Device Certification
ECM Israel – Medical Devices Certification

When I try to follow the LI link to their websites, McAfee tell me to "Whoa!"  ECM Israel's listing describes it as an "Italian Notified Body providing efficient and high quality Certification and Testing Services."

There is also a Company named "Ente Certificazione Macchine."  When I click on the LI link to its website, McAfee stays quiet, so I was able to learn that it is "an ISO 17065 Notified Body (1282) and an accredited ISO 17025 Testing Lab (1515 L)."  All three companies post the same logo.

This could all be due to some of the many glitches in LI's software, a complicated corporate NB structure, and/or perhaps a marketing team that doesn't know much about FDA regulation of medical devices.

It has also occurred to me that the EU situation seems ripe for NB-related scams, including the spoofing of legitimate NBs and the creation of fake NBs.  It's clear from posts in the Forum and on LinkedIn that there are plenty of device companies out there that haven't been paying attention, and that are becoming frantic when they realize that the NB ship may have sailed.  A device company that is only just waking up to the realities in the EU seems like an easy target for a scam.

I did a little googling and found this news release about ECM America:

https://www.healthcaredive.com/press-release/20180829-ecm-america-mdd-notified-body-launches-us-dedicated-website-ecmamericaco/

It uses the same logo also.  The announcement states that it also offers ISO 13485 certification, and thereby stands to benefit financially if medical device manufacturers think they must have ISO 13485 to market medical devices in the US.   The announcement doesn't indicate that it has been designated under either MDD or MDR.  When I try to go to its website (https://ecmamerica.com/), McAfee tells me to whoa again.

Anyway, enough time spent on something that, however fascinating, is not a current priority for me.  Maybe one of you guys might want to investigate further....

ECM – Medical Device Certification
ECM Israel – Medical Devices Certification

When I try to follow the LI link to their websites, McAfee tell me to "Whoa!"  ECM Israel's listing describes it as an "Italian Notified Body providing efficient and high quality Certification and Testing Services."

There is also a Company named "Ente Certificazione Macchine."  When I click on the LI link to its website, McAfee stays quiet, so I was able to learn that it is "an ISO 17065 Notified Body (1282) and an accredited ISO 17025 Testing Lab (1515 L)."  All three companies post the same logo.

This could all be due to some of the many glitches in LI's software, a complicated corporate NB structure, and/or perhaps a marketing team that doesn't know much about FDA regulation of medical devices.

It has also occurred to me that the EU situation seems ripe for NB-related scams, including the spoofing of legitimate NBs and the creation of fake NBs.  It's clear from posts in the Forum and on LinkedIn that there are plenty of device companies out there that haven't been paying attention, and that are becoming frantic when they realize that the NB ship may have sailed.  A device company that is only just waking up to the realities in the EU seems like an easy target for a scam.

I did a little googling and found this news release about ECM America:

https://www.healthcaredive.com/press-release/20180829-ecm-america-mdd-notified-body-launches-us-dedicated-website-ecmamericaco/

It uses the same logo also.  The announcement states that it also offers ISO 13485 certification, and thereby stands to benefit financially if medical device manufacturers think they must have ISO 13485 to market medical devices in the US.   The announcement doesn't indicate that it has been designated under either MDD or MDR.  When I try to go to its website (https://ecmamerica.com/), McAfee tells me to whoa again.

Anyway, enough time spent on something that, however fascinating, is not a current priority for me.  Maybe one of you guys might want to investigate further....

ECM – Medical Device Certification
ECM Israel – Medical Devices Certification

When I try to follow the LI link to their websites, McAfee tell me to "Whoa!"  ECM Israel's listing describes it as an "Italian Notified Body providing efficient and high quality Certification and Testing Services."

There is also a Company named "Ente Certificazione Macchine."  When I click on the LI link to its website, McAfee stays quiet, so I was able to learn that it is "an ISO 17065 Notified Body (1282) and an accredited ISO 17025 Testing Lab (1515 L)."  All three companies post the same logo.

This could all be due to some of the many glitches in LI's software, a complicated corporate NB structure, and/or perhaps a marketing team that doesn't know much about FDA regulation of medical devices.

It has also occurred to me that the EU situation seems ripe for NB-related scams, including the spoofing of legitimate NBs and the creation of fake NBs.  It's clear from posts in the Forum and on LinkedIn that there are plenty of device companies out there that haven't been paying attention, and that are becoming frantic when they realize that the NB ship may have sailed.  A device company that is only just waking up to the realities in the EU seems like an easy target for a scam.

I did a little googling and found this news release about ECM America:

https://www.healthcaredive.com/press-release/20180829-ecm-america-mdd-notified-body-launches-us-dedicated-website-ecmamericaco/

It uses the same logo also.  The announcement states that it also offers ISO 13485 certification, and thereby stands to benefit financially if medical device manufacturers think they must have ISO 13485 to market medical devices in the US.   The announcement doesn't indicate that it has been designated under either MDD or MDR.  When I try to go to its website (https://ecmamerica.com/), McAfee tells me to whoa again.

Anyway, enough time spent on something that, however fascinating, is not a current priority for me.  Maybe one of you guys might want to investigate further....

ECM – Medical Device Certification
ECM Israel – Medical Devices Certification

When I try to follow the LI link to their websites, McAfee tell me to "Whoa!"  ECM Israel's listing describes it as an "Italian Notified Body providing efficient and high quality Certification and Testing Services."

There is also a Company named "Ente Certificazione Macchine."  When I click on the LI link to its website, McAfee stays quiet, so I was able to learn that it is "an ISO 17065 Notified Body (1282) and an accredited ISO 17025 Testing Lab (1515 L)."  All three companies post the same logo.

This could all be due to some of the many glitches in LI's software, a complicated corporate NB structure, and/or perhaps a marketing team that doesn't know much about FDA regulation of medical devices.

It has also occurred to me that the EU situation seems ripe for NB-related scams, including the spoofing of legitimate NBs and the creation of fake NBs.  It's clear from posts in the Forum and on LinkedIn that there are plenty of device companies out there that haven't been paying attention, and that are becoming frantic when they realize that the NB ship may have sailed.  A device company that is only just waking up to the realities in the EU seems like an easy target for a scam.

I did a little googling and found this news release about ECM America:

https://www.healthcaredive.com/press-release/20180829-ecm-america-mdd-notified-body-launches-us-dedicated-website-ecmamericaco/

It uses the same logo also.  The announcement states that it also offers ISO 13485 certification, and thereby stands to benefit financially if medical device manufacturers think they must have ISO 13485 to market medical devices in the US.   The announcement doesn't indicate that it has been designated under either MDD or MDR.  When I try to go to its website (https://ecmamerica.com/), McAfee tells me to whoa again.

Anyway, enough time spent on something that, however fascinating, is not a current priority for me.  Maybe one of you guys might want to investigate further....

ECM – Medical Device Certification
ECM Israel – Medical Devices Certification

When I try to follow the LI link to their websites, McAfee tell me to "Whoa!"  ECM Israel's listing describes it as an "Italian Notified Body providing efficient and high quality Certification and Testing Services."

There is also a Company named "Ente Certificazione Macchine."  When I click on the LI link to its website, McAfee stays quiet, so I was able to learn that it is "an ISO 17065 Notified Body (1282) and an accredited ISO 17025 Testing Lab (1515 L)."  All three companies post the same logo.

This could all be due to some of the many glitches in LI's software, a complicated corporate NB structure, and/or perhaps a marketing team that doesn't know much about FDA regulation of medical devices.

It has also occurred to me that the EU situation seems ripe for NB-related scams, including the spoofing of legitimate NBs and the creation of fake NBs.  It's clear from posts in the Forum and on LinkedIn that there are plenty of device companies out there that haven't been paying attention, and that are becoming frantic when they realize that the NB ship may have sailed.  A device company that is only just waking up to the realities in the EU seems like an easy target for a scam.

I did a little googling and found this news release about ECM America:

https://www.healthcaredive.com/press-release/20180829-ecm-america-mdd-notified-body-launches-us-dedicated-website-ecmamericaco/

It uses the same logo also.  The announcement states that it also offers ISO 13485 certification, and thereby stands to benefit financially if medical device manufacturers think they must have ISO 13485 to market medical devices in the US.   The announcement doesn't indicate that it has been designated under either MDD or MDR.  When I try to go to its website (https://ecmamerica.com/), McAfee tells me to whoa again.

Anyway, enough time spent on something that, however fascinating, is not a current priority for me.  Maybe one of you guys might want to investigate further....

ECM – Medical Device Certification
ECM Israel – Medical Devices Certification

When I try to follow the LI link to their websites, McAfee tell me to "Whoa!"  ECM Israel's listing describes it as an "Italian Notified Body providing efficient and high quality Certification and Testing Services."

There is also a Company named "Ente Certificazione Macchine."  When I click on the LI link to its website, McAfee stays quiet, so I was able to learn that it is "an ISO 17065 Notified Body (1282) and an accredited ISO 17025 Testing Lab (1515 L)."  All three companies post the same logo.

This could all be due to some of the many glitches in LI's software, a complicated corporate NB structure, and/or perhaps a marketing team that doesn't know much about FDA regulation of medical devices.

It has also occurred to me that the EU situation seems ripe for NB-related scams, including the spoofing of legitimate NBs and the creation of fake NBs.  It's clear from posts in the Forum and on LinkedIn that there are plenty of device companies out there that haven't been paying attention, and that are becoming frantic when they realize that the NB ship may have sailed.  A device company that is only just waking up to the realities in the EU seems like an easy target for a scam.

I did a little googling and found this news release about ECM America:

https://www.healthcaredive.com/press-release/20180829-ecm-america-mdd-notified-body-launches-us-dedicated-website-ecmamericaco/

It uses the same logo also.  The announcement states that it also offers ISO 13485 certification, and thereby stands to benefit financially if medical device manufacturers think they must have ISO 13485 to market medical devices in the US.   The announcement doesn't indicate that it has been designated under either MDD or MDR.  When I try to go to its website (https://ecmamerica.com/), McAfee tells me to whoa again.

Anyway, enough time spent on something that, however fascinating, is not a current priority for me.  Maybe one of you guys might want to investigate further....

ECM – Medical Device Certification
ECM Israel – Medical Devices Certification

When I try to follow the LI link to their websites, McAfee tell me to "Whoa!"  ECM Israel's listing describes it as an "Italian Notified Body providing efficient and high quality Certification and Testing Services."

There is also a Company named "Ente Certificazione Macchine."  When I click on the LI link to its website, McAfee stays quiet, so I was able to learn that it is "an ISO 17065 Notified Body (1282) and an accredited ISO 17025 Testing Lab (1515 L)."  All three companies post the same logo.

This could all be due to some of the many glitches in LI's software, a complicated corporate NB structure, and/or perhaps a marketing team that doesn't know much about FDA regulation of medical devices.

It has also occurred to me that the EU situation seems ripe for NB-related scams, including the spoofing of legitimate NBs and the creation of fake NBs.  It's clear from posts in the Forum and on LinkedIn that there are plenty of device companies out there that haven't been paying attention, and that are becoming frantic when they realize that the NB ship may have sailed.  A device company that is only just waking up to the realities in the EU seems like an easy target for a scam.

I did a little googling and found this news release about ECM America:

https://www.healthcaredive.com/press-release/20180829-ecm-america-mdd-notified-body-launches-us-dedicated-website-ecmamericaco/

It uses the same logo also.  The announcement states that it also offers ISO 13485 certification, and thereby stands to benefit financially if medical device manufacturers think they must have ISO 13485 to market medical devices in the US.   The announcement doesn't indicate that it has been designated under either MDD or MDR.  When I try to go to its website (https://ecmamerica.com/), McAfee tells me to whoa again.

Anyway, enough time spent on something that, however fascinating, is not a current priority for me.  Maybe one of you guys might want to investigate further....

ECM – Medical Device Certification
ECM Israel – Medical Devices Certification

When I try to follow the LI link to their websites, McAfee tell me to "Whoa!"  ECM Israel's listing describes it as an "Italian Notified Body providing efficient and high quality Certification and Testing Services."

There is also a Company named "Ente Certificazione Macchine."  When I click on the LI link to its website, McAfee stays quiet, so I was able to learn that it is "an ISO 17065 Notified Body (1282) and an accredited ISO 17025 Testing Lab (1515 L)."  All three companies post the same logo.

This could all be due to some of the many glitches in LI's software, a complicated corporate NB structure, and/or perhaps a marketing team that doesn't know much about FDA regulation of medical devices.

It has also occurred to me that the EU situation seems ripe for NB-related scams, including the spoofing of legitimate NBs and the creation of fake NBs.  It's clear from posts in the Forum and on LinkedIn that there are plenty of device companies out there that haven't been paying attention, and that are becoming frantic when they realize that the NB ship may have sailed.  A device company that is only just waking up to the realities in the EU seems like an easy target for a scam.

I did a little googling and found this news release about ECM America:

https://www.healthcaredive.com/press-release/20180829-ecm-america-mdd-notified-body-launches-us-dedicated-website-ecmamericaco/

It uses the same logo also.  The announcement states that it also offers ISO 13485 certification, and thereby stands to benefit financially if medical device manufacturers think they must have ISO 13485 to market medical devices in the US.   The announcement doesn't indicate that it has been designated under either MDD or MDR.  When I try to go to its website (https://ecmamerica.com/), McAfee tells me to whoa again.

Anyway, enough time spent on something that, however fascinating, is not a current priority for me.  Maybe one of you guys might want to investigate further....

ECM – Medical Device Certification
ECM Israel – Medical Devices Certification

When I try to follow the LI link to their websites, McAfee tell me to "Whoa!"  ECM Israel's listing describes it as an "Italian Notified Body providing efficient and high quality Certification and Testing Services."

There is also a Company named "Ente Certificazione Macchine."  When I click on the LI link to its website, McAfee stays quiet, so I was able to learn that it is "an ISO 17065 Notified Body (1282) and an accredited ISO 17025 Testing Lab (1515 L)."  All three companies post the same logo.

This could all be due to some of the many glitches in LI's software, a complicated corporate NB structure, and/or perhaps a marketing team that doesn't know much about FDA regulation of medical devices.

It has also occurred to me that the EU situation seems ripe for NB-related scams, including the spoofing of legitimate NBs and the creation of fake NBs.  It's clear from posts in the Forum and on LinkedIn that there are plenty of device companies out there that haven't been paying attention, and that are becoming frantic when they realize that the NB ship may have sailed.  A device company that is only just waking up to the realities in the EU seems like an easy target for a scam.

I did a little googling and found this news release about ECM America:

https://www.healthcaredive.com/press-release/20180829-ecm-america-mdd-notified-body-launches-us-dedicated-website-ecmamericaco/

It uses the same logo also.  The announcement states that it also offers ISO 13485 certification, and thereby stands to benefit financially if medical device manufacturers think they must have ISO 13485 to market medical devices in the US.   The announcement doesn't indicate that it has been designated under either MDD or MDR.  When I try to go to its website (https://ecmamerica.com/), McAfee tells me to whoa again.

Anyway, enough time spent on something that, however fascinating, is not a current priority for me.  Maybe one of you guys might want to investigate further....

Arthur,

I have a question about your sentence, "ISO 13485 will be in the first batch of standards harmonized with MDR - as per the recent request to CEN from the commission."

I could not get the link to open. I infer you refer to "Draft standardisation request to the European Committee for Standardisation and the European Committee for Electrotechnical Standardization as regards medical devices in support of Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746 of the European Parliament and of the Council"

I note the request is to standardize EN ISO 13485:2016+AC:2018 with a "Deadline for the adoption" of May 26, 2020. There is also a footnote that says, "'Adoption' refers to the relevant European standardisation organisation making an adopted standard available to its members or the public."

As I understand the processes one step is standardization, when mean the standards organization makes it available.

Harmonization is subsequent step which requires publication in the Official Journal. There are many CEN standards, for example, that are not harmonized. In some cases, the prior version, not the current version, is listed in the Official Journal as a harmonized standard.

Some standards are never harmonized, such as "EN 13485:2001 Thermometers for measuring the air and product temperature for the transport, storage and distribution of chilled, frozen, deep-frozen/quick-frozen food and ice cream - Tests, performance, suitability".

Do you have a list of standards for harmonization that extends beyond the list for standardization?

• from working cooperatively to confrontationally
• from having expert experienced auditors to speedily trained box checkers
• from treating the manufacturer as the customer to be terrified of their CA
• from standing-up to irrational non-scientific CA requirements to just re-iterating them

• from working cooperatively to confrontationally
• from having expert experienced auditors to speedily trained box checkers
• from treating the manufacturer as the customer to be terrified of their CA
• from standing-up to irrational non-scientific CA requirements to just re-iterating them

• from working cooperatively to confrontationally
• from having expert experienced auditors to speedily trained box checkers
• from treating the manufacturer as the customer to be terrified of their CA
• from standing-up to irrational non-scientific CA requirements to just re-iterating them