Regulatory Open Forum

In your current QS, where do you place regulatory SUBMISSIONS?  In all of my previous companies, submissions themselves were a parallel path to design controls within the "cradle to grave" product realization process.  Obviously, any regulatory REQUIREMENTS related to the design of the device, labelling, testing, etc. are inputs to design controls.

I'm talking about the act of preparing and submitting a premarket notification/application and the interaction with the regulatory authority.  Assuming you've done a solid job of making sure the regulatory requirements were addressed during design controls, the resulting DHF documentation should be suitable for the countries defined at the beginning of the project and likely some "add-on" countries after the fact.  Furthermore, the country-specific registrations could be done shortly after V&V is complete or, in some cases, years after.

Why would you put the SUBMISSION process as part of design controls?  I am vehemently against this approach as I feel it would add unnecessary burden not only to the submissions, but to the design controls process.  Unless I was planning to submit in a new country with a requirement that would impact the existing DHF documentation, it just simply doesn't make sense to me for the submissions requiring even so much as a design review.

Also, have you ever used a regulatory clearance/approval as design validation?

Not sure if this is just simply out of my comfort zone and truly does have merit, or if it just simply doesn't make sense.

Looking forward to your input (and hopefully some confirmation that I'm not crazy)

Tina

• The design and development output would be the submission itself [i.e., FDA 510(k) # K17abcd; EC Technical Documentation File / Design Dossier # abc; Canadian Medical Device License Application file # xyz; etc.]
• The design verification is the FDA 510(k)-clearance letter; the EC Certificate; the Canadian Medical Device License; the ARTG registration, etc.
• The design validation may in this case also be the aforesaid clearances/approvals, as it can be argued that the user needs the product to be the subject of a successful premarket regulatory submission.  Alternatively, it would typically also be acceptable to cite the device's successful design validation testing, which shows that the cleared/approved subject device meets user needs/intended uses.

In your current QS, where do you place regulatory SUBMISSIONS?  In all of my previous companies, submissions themselves were a parallel path to design controls within the "cradle to grave" product realization process.  Obviously, any regulatory REQUIREMENTS related to the design of the device, labelling, testing, etc. are inputs to design controls.

I'm talking about the act of preparing and submitting a premarket notification/application and the interaction with the regulatory authority.  Assuming you've done a solid job of making sure the regulatory requirements were addressed during design controls, the resulting DHF documentation should be suitable for the countries defined at the beginning of the project and likely some "add-on" countries after the fact.  Furthermore, the country-specific registrations could be done shortly after V&V is complete or, in some cases, years after.

Why would you put the SUBMISSION process as part of design controls?  I am vehemently against this approach as I feel it would add unnecessary burden not only to the submissions, but to the design controls process.  Unless I was planning to submit in a new country with a requirement that would impact the existing DHF documentation, it just simply doesn't make sense to me for the submissions requiring even so much as a design review.

Also, have you ever used a regulatory clearance/approval as design validation?

Not sure if this is just simply out of my comfort zone and truly does have merit, or if it just simply doesn't make sense.

Looking forward to your input (and hopefully some confirmation that I'm not crazy)

Tina

• The design and development output would be the submission itself [i.e., FDA 510(k) # K17abcd; EC Technical Documentation File / Design Dossier # abc; Canadian Medical Device License Application file # xyz; etc.]
• The design verification is the FDA 510(k)-clearance letter; the EC Certificate; the Canadian Medical Device License; the ARTG registration, etc.
• The design validation may in this case also be the aforesaid clearances/approvals, as it can be argued that the user needs the product to be the subject of a successful premarket regulatory submission.  Alternatively, it would typically also be acceptable to cite the device's successful design validation testing, which shows that the cleared/approved subject device meets user needs/intended uses.

In your current QS, where do you place regulatory SUBMISSIONS?  In all of my previous companies, submissions themselves were a parallel path to design controls within the "cradle to grave" product realization process.  Obviously, any regulatory REQUIREMENTS related to the design of the device, labelling, testing, etc. are inputs to design controls.

I'm talking about the act of preparing and submitting a premarket notification/application and the interaction with the regulatory authority.  Assuming you've done a solid job of making sure the regulatory requirements were addressed during design controls, the resulting DHF documentation should be suitable for the countries defined at the beginning of the project and likely some "add-on" countries after the fact.  Furthermore, the country-specific registrations could be done shortly after V&V is complete or, in some cases, years after.

Why would you put the SUBMISSION process as part of design controls?  I am vehemently against this approach as I feel it would add unnecessary burden not only to the submissions, but to the design controls process.  Unless I was planning to submit in a new country with a requirement that would impact the existing DHF documentation, it just simply doesn't make sense to me for the submissions requiring even so much as a design review.

Also, have you ever used a regulatory clearance/approval as design validation?

Not sure if this is just simply out of my comfort zone and truly does have merit, or if it just simply doesn't make sense.

Looking forward to your input (and hopefully some confirmation that I'm not crazy)

Tina

Hi Tina!

In over twenty years of studying, learning, being taught by accomplished mentors, applying design controls in practice, teaching design controls, and becoming a mentor myself, I've routinely seen the premarket submission requirements articulated in the design inputs.  Looking back, I guess I never questioned it, but I'm certainly glad to be thinking about it now.

One thing we know for certain is that FDA, ISO 13485, AdvaMed, AAMI and others all indicate that the design inputs are to include regulatory requirements.  We also know that the design inputs must not be incomplete or ambiguous.  Question for your/the Forum's consideration: What would be our rationale for including some key regulatory requirements that are important to user needs (like those you've listed) but not others (like the requirement to meet premarket clearance/approval)?

In theory, a particular jurisdiction's premarket regulatory submission requirements are ultimately intended to facilitate patient/user safety. In other words, marketing a device without the appropriate premarket agency reviews is reasonably related to compromised public health.  For example, the lack of proper premarket review is what ultimately led to establishing the U.S. FDA's premarket requirements after the U.S. sulfanilamide tragedies in 1937.  So, based on that perspective, I'd say it seems reasonable to include the premarket submissions with other important regulatory requirements in the design inputs.  Thereafter, obtaining a regulatory approval could be viewed as validating the design of the device, as design validation means confirming that the design meets user needs, where the user needs seem to include proper premarket agency review.

• The design and development output would be the submission itself [i.e., FDA 510(k) # K17abcd; EC Technical Documentation File / Design Dossier # abc; Canadian Medical Device License Application file # xyz; etc.]
• The design verification is the FDA 510(k)-clearance letter; the EC Certificate; the Canadian Medical Device License; the ARTG registration, etc.
• The design validation may in this case also be the aforesaid clearances/approvals, as it can be argued that the user needs the product to be the subject of a successful premarket regulatory submission.  Alternatively, it would typically also be acceptable to cite the device's successful design validation testing, which shows that the cleared/approved subject device meets user needs/intended uses.

In your current QS, where do you place regulatory SUBMISSIONS?  In all of my previous companies, submissions themselves were a parallel path to design controls within the "cradle to grave" product realization process.  Obviously, any regulatory REQUIREMENTS related to the design of the device, labelling, testing, etc. are inputs to design controls.

I'm talking about the act of preparing and submitting a premarket notification/application and the interaction with the regulatory authority.  Assuming you've done a solid job of making sure the regulatory requirements were addressed during design controls, the resulting DHF documentation should be suitable for the countries defined at the beginning of the project and likely some "add-on" countries after the fact.  Furthermore, the country-specific registrations could be done shortly after V&V is complete or, in some cases, years after.

Why would you put the SUBMISSION process as part of design controls?  I am vehemently against this approach as I feel it would add unnecessary burden not only to the submissions, but to the design controls process.  Unless I was planning to submit in a new country with a requirement that would impact the existing DHF documentation, it just simply doesn't make sense to me for the submissions requiring even so much as a design review.

Also, have you ever used a regulatory clearance/approval as design validation?

Not sure if this is just simply out of my comfort zone and truly does have merit, or if it just simply doesn't make sense.

Looking forward to your input (and hopefully some confirmation that I'm not crazy)

Tina

• The design and development output would be the submission itself [i.e., FDA 510(k) # K17abcd; EC Technical Documentation File / Design Dossier # abc; Canadian Medical Device License Application file # xyz; etc.]
• The design verification is the FDA 510(k)-clearance letter; the EC Certificate; the Canadian Medical Device License; the ARTG registration, etc.
• The design validation may in this case also be the aforesaid clearances/approvals, as it can be argued that the user needs the product to be the subject of a successful premarket regulatory submission.  Alternatively, it would typically also be acceptable to cite the device's successful design validation testing, which shows that the cleared/approved subject device meets user needs/intended uses.

In your current QS, where do you place regulatory SUBMISSIONS?  In all of my previous companies, submissions themselves were a parallel path to design controls within the "cradle to grave" product realization process.  Obviously, any regulatory REQUIREMENTS related to the design of the device, labelling, testing, etc. are inputs to design controls.

I'm talking about the act of preparing and submitting a premarket notification/application and the interaction with the regulatory authority.  Assuming you've done a solid job of making sure the regulatory requirements were addressed during design controls, the resulting DHF documentation should be suitable for the countries defined at the beginning of the project and likely some "add-on" countries after the fact.  Furthermore, the country-specific registrations could be done shortly after V&V is complete or, in some cases, years after.

Why would you put the SUBMISSION process as part of design controls?  I am vehemently against this approach as I feel it would add unnecessary burden not only to the submissions, but to the design controls process.  Unless I was planning to submit in a new country with a requirement that would impact the existing DHF documentation, it just simply doesn't make sense to me for the submissions requiring even so much as a design review.

Also, have you ever used a regulatory clearance/approval as design validation?

Not sure if this is just simply out of my comfort zone and truly does have merit, or if it just simply doesn't make sense.

Looking forward to your input (and hopefully some confirmation that I'm not crazy)

Tina

• The design and development output would be the submission itself [i.e., FDA 510(k) # K17abcd; EC Technical Documentation File / Design Dossier # abc; Canadian Medical Device License Application file # xyz; etc.]
• The design verification is the FDA 510(k)-clearance letter; the EC Certificate; the Canadian Medical Device License; the ARTG registration, etc.
• The design validation may in this case also be the aforesaid clearances/approvals, as it can be argued that the user needs the product to be the subject of a successful premarket regulatory submission.  Alternatively, it would typically also be acceptable to cite the device's successful design validation testing, which shows that the cleared/approved subject device meets user needs/intended uses.

In your current QS, where do you place regulatory SUBMISSIONS?  In all of my previous companies, submissions themselves were a parallel path to design controls within the "cradle to grave" product realization process.  Obviously, any regulatory REQUIREMENTS related to the design of the device, labelling, testing, etc. are inputs to design controls.

I'm talking about the act of preparing and submitting a premarket notification/application and the interaction with the regulatory authority.  Assuming you've done a solid job of making sure the regulatory requirements were addressed during design controls, the resulting DHF documentation should be suitable for the countries defined at the beginning of the project and likely some "add-on" countries after the fact.  Furthermore, the country-specific registrations could be done shortly after V&V is complete or, in some cases, years after.

Why would you put the SUBMISSION process as part of design controls?  I am vehemently against this approach as I feel it would add unnecessary burden not only to the submissions, but to the design controls process.  Unless I was planning to submit in a new country with a requirement that would impact the existing DHF documentation, it just simply doesn't make sense to me for the submissions requiring even so much as a design review.

Also, have you ever used a regulatory clearance/approval as design validation?

Not sure if this is just simply out of my comfort zone and truly does have merit, or if it just simply doesn't make sense.

Looking forward to your input (and hopefully some confirmation that I'm not crazy)

Tina

• The design and development output would be the submission itself [i.e., FDA 510(k) # K17abcd; EC Technical Documentation File / Design Dossier # abc; Canadian Medical Device License Application file # xyz; etc.]
• The design verification is the FDA 510(k)-clearance letter; the EC Certificate; the Canadian Medical Device License; the ARTG registration, etc.
• The design validation may in this case also be the aforesaid clearances/approvals, as it can be argued that the user needs the product to be the subject of a successful premarket regulatory submission.  Alternatively, it would typically also be acceptable to cite the device's successful design validation testing, which shows that the cleared/approved subject device meets user needs/intended uses.

In your current QS, where do you place regulatory SUBMISSIONS?  In all of my previous companies, submissions themselves were a parallel path to design controls within the "cradle to grave" product realization process.  Obviously, any regulatory REQUIREMENTS related to the design of the device, labelling, testing, etc. are inputs to design controls.

I'm talking about the act of preparing and submitting a premarket notification/application and the interaction with the regulatory authority.  Assuming you've done a solid job of making sure the regulatory requirements were addressed during design controls, the resulting DHF documentation should be suitable for the countries defined at the beginning of the project and likely some "add-on" countries after the fact.  Furthermore, the country-specific registrations could be done shortly after V&V is complete or, in some cases, years after.

Why would you put the SUBMISSION process as part of design controls?  I am vehemently against this approach as I feel it would add unnecessary burden not only to the submissions, but to the design controls process.  Unless I was planning to submit in a new country with a requirement that would impact the existing DHF documentation, it just simply doesn't make sense to me for the submissions requiring even so much as a design review.

Also, have you ever used a regulatory clearance/approval as design validation?

Not sure if this is just simply out of my comfort zone and truly does have merit, or if it just simply doesn't make sense.

Looking forward to your input (and hopefully some confirmation that I'm not crazy)

Tina

• The design and development output would be the submission itself [i.e., FDA 510(k) # K17abcd; EC Technical Documentation File / Design Dossier # abc; Canadian Medical Device License Application file # xyz; etc.]
• The design verification is the FDA 510(k)-clearance letter; the EC Certificate; the Canadian Medical Device License; the ARTG registration, etc.
• The design validation may in this case also be the aforesaid clearances/approvals, as it can be argued that the user needs the product to be the subject of a successful premarket regulatory submission.  Alternatively, it would typically also be acceptable to cite the device's successful design validation testing, which shows that the cleared/approved subject device meets user needs/intended uses.

In your current QS, where do you place regulatory SUBMISSIONS?  In all of my previous companies, submissions themselves were a parallel path to design controls within the "cradle to grave" product realization process.  Obviously, any regulatory REQUIREMENTS related to the design of the device, labelling, testing, etc. are inputs to design controls.

I'm talking about the act of preparing and submitting a premarket notification/application and the interaction with the regulatory authority.  Assuming you've done a solid job of making sure the regulatory requirements were addressed during design controls, the resulting DHF documentation should be suitable for the countries defined at the beginning of the project and likely some "add-on" countries after the fact.  Furthermore, the country-specific registrations could be done shortly after V&V is complete or, in some cases, years after.

Why would you put the SUBMISSION process as part of design controls?  I am vehemently against this approach as I feel it would add unnecessary burden not only to the submissions, but to the design controls process.  Unless I was planning to submit in a new country with a requirement that would impact the existing DHF documentation, it just simply doesn't make sense to me for the submissions requiring even so much as a design review.

Also, have you ever used a regulatory clearance/approval as design validation?

Not sure if this is just simply out of my comfort zone and truly does have merit, or if it just simply doesn't make sense.

Looking forward to your input (and hopefully some confirmation that I'm not crazy)

Tina

• The design and development output would be the submission itself [i.e., FDA 510(k) # K17abcd; EC Technical Documentation File / Design Dossier # abc; Canadian Medical Device License Application file # xyz; etc.]
• The design verification is the FDA 510(k)-clearance letter; the EC Certificate; the Canadian Medical Device License; the ARTG registration, etc.
• The design validation may in this case also be the aforesaid clearances/approvals, as it can be argued that the user needs the product to be the subject of a successful premarket regulatory submission.  Alternatively, it would typically also be acceptable to cite the device's successful design validation testing, which shows that the cleared/approved subject device meets user needs/intended uses.

In your current QS, where do you place regulatory SUBMISSIONS?  In all of my previous companies, submissions themselves were a parallel path to design controls within the "cradle to grave" product realization process.  Obviously, any regulatory REQUIREMENTS related to the design of the device, labelling, testing, etc. are inputs to design controls.

I'm talking about the act of preparing and submitting a premarket notification/application and the interaction with the regulatory authority.  Assuming you've done a solid job of making sure the regulatory requirements were addressed during design controls, the resulting DHF documentation should be suitable for the countries defined at the beginning of the project and likely some "add-on" countries after the fact.  Furthermore, the country-specific registrations could be done shortly after V&V is complete or, in some cases, years after.

Why would you put the SUBMISSION process as part of design controls?  I am vehemently against this approach as I feel it would add unnecessary burden not only to the submissions, but to the design controls process.  Unless I was planning to submit in a new country with a requirement that would impact the existing DHF documentation, it just simply doesn't make sense to me for the submissions requiring even so much as a design review.

Also, have you ever used a regulatory clearance/approval as design validation?

Not sure if this is just simply out of my comfort zone and truly does have merit, or if it just simply doesn't make sense.

Looking forward to your input (and hopefully some confirmation that I'm not crazy)

Tina

In your current QS, where do you place regulatory SUBMISSIONS?  In all of my previous companies, submissions themselves were a parallel path to design controls within the "cradle to grave" product realization process.  Obviously, any regulatory REQUIREMENTS related to the design of the device, labelling, testing, etc. are inputs to design controls.

I'm talking about the act of preparing and submitting a premarket notification/application and the interaction with the regulatory authority.  Assuming you've done a solid job of making sure the regulatory requirements were addressed during design controls, the resulting DHF documentation should be suitable for the countries defined at the beginning of the project and likely some "add-on" countries after the fact.  Furthermore, the country-specific registrations could be done shortly after V&V is complete or, in some cases, years after.

Why would you put the SUBMISSION process as part of design controls?  I am vehemently against this approach as I feel it would add unnecessary burden not only to the submissions, but to the design controls process.  Unless I was planning to submit in a new country with a requirement that would impact the existing DHF documentation, it just simply doesn't make sense to me for the submissions requiring even so much as a design review.

Also, have you ever used a regulatory clearance/approval as design validation?

Not sure if this is just simply out of my comfort zone and truly does have merit, or if it just simply doesn't make sense.

Looking forward to your input (and hopefully some confirmation that I'm not crazy)

Tina

In your current QS, where do you place regulatory SUBMISSIONS?  In all of my previous companies, submissions themselves were a parallel path to design controls within the "cradle to grave" product realization process.  Obviously, any regulatory REQUIREMENTS related to the design of the device, labelling, testing, etc. are inputs to design controls.

I'm talking about the act of preparing and submitting a premarket notification/application and the interaction with the regulatory authority.  Assuming you've done a solid job of making sure the regulatory requirements were addressed during design controls, the resulting DHF documentation should be suitable for the countries defined at the beginning of the project and likely some "add-on" countries after the fact.  Furthermore, the country-specific registrations could be done shortly after V&V is complete or, in some cases, years after.

Why would you put the SUBMISSION process as part of design controls?  I am vehemently against this approach as I feel it would add unnecessary burden not only to the submissions, but to the design controls process.  Unless I was planning to submit in a new country with a requirement that would impact the existing DHF documentation, it just simply doesn't make sense to me for the submissions requiring even so much as a design review.

Also, have you ever used a regulatory clearance/approval as design validation?

Not sure if this is just simply out of my comfort zone and truly does have merit, or if it just simply doesn't make sense.

Looking forward to your input (and hopefully some confirmation that I'm not crazy)

Tina

In your current QS, where do you place regulatory SUBMISSIONS?  In all of my previous companies, submissions themselves were a parallel path to design controls within the "cradle to grave" product realization process.  Obviously, any regulatory REQUIREMENTS related to the design of the device, labelling, testing, etc. are inputs to design controls.

I'm talking about the act of preparing and submitting a premarket notification/application and the interaction with the regulatory authority.  Assuming you've done a solid job of making sure the regulatory requirements were addressed during design controls, the resulting DHF documentation should be suitable for the countries defined at the beginning of the project and likely some "add-on" countries after the fact.  Furthermore, the country-specific registrations could be done shortly after V&V is complete or, in some cases, years after.

Why would you put the SUBMISSION process as part of design controls?  I am vehemently against this approach as I feel it would add unnecessary burden not only to the submissions, but to the design controls process.  Unless I was planning to submit in a new country with a requirement that would impact the existing DHF documentation, it just simply doesn't make sense to me for the submissions requiring even so much as a design review.

Also, have you ever used a regulatory clearance/approval as design validation?

Not sure if this is just simply out of my comfort zone and truly does have merit, or if it just simply doesn't make sense.

Looking forward to your input (and hopefully some confirmation that I'm not crazy)

Tina

In your current QS, where do you place regulatory SUBMISSIONS?  In all of my previous companies, submissions themselves were a parallel path to design controls within the "cradle to grave" product realization process.  Obviously, any regulatory REQUIREMENTS related to the design of the device, labelling, testing, etc. are inputs to design controls.

I'm talking about the act of preparing and submitting a premarket notification/application and the interaction with the regulatory authority.  Assuming you've done a solid job of making sure the regulatory requirements were addressed during design controls, the resulting DHF documentation should be suitable for the countries defined at the beginning of the project and likely some "add-on" countries after the fact.  Furthermore, the country-specific registrations could be done shortly after V&V is complete or, in some cases, years after.

Why would you put the SUBMISSION process as part of design controls?  I am vehemently against this approach as I feel it would add unnecessary burden not only to the submissions, but to the design controls process.  Unless I was planning to submit in a new country with a requirement that would impact the existing DHF documentation, it just simply doesn't make sense to me for the submissions requiring even so much as a design review.

Also, have you ever used a regulatory clearance/approval as design validation?

Not sure if this is just simply out of my comfort zone and truly does have merit, or if it just simply doesn't make sense.

Looking forward to your input (and hopefully some confirmation that I'm not crazy)

Tina

In your current QS, where do you place regulatory SUBMISSIONS?  In all of my previous companies, submissions themselves were a parallel path to design controls within the "cradle to grave" product realization process.  Obviously, any regulatory REQUIREMENTS related to the design of the device, labelling, testing, etc. are inputs to design controls.

I'm talking about the act of preparing and submitting a premarket notification/application and the interaction with the regulatory authority.  Assuming you've done a solid job of making sure the regulatory requirements were addressed during design controls, the resulting DHF documentation should be suitable for the countries defined at the beginning of the project and likely some "add-on" countries after the fact.  Furthermore, the country-specific registrations could be done shortly after V&V is complete or, in some cases, years after.

Why would you put the SUBMISSION process as part of design controls?  I am vehemently against this approach as I feel it would add unnecessary burden not only to the submissions, but to the design controls process.  Unless I was planning to submit in a new country with a requirement that would impact the existing DHF documentation, it just simply doesn't make sense to me for the submissions requiring even so much as a design review.

Also, have you ever used a regulatory clearance/approval as design validation?

Not sure if this is just simply out of my comfort zone and truly does have merit, or if it just simply doesn't make sense.

Looking forward to your input (and hopefully some confirmation that I'm not crazy)

Tina

In your current QS, where do you place regulatory SUBMISSIONS?  In all of my previous companies, submissions themselves were a parallel path to design controls within the "cradle to grave" product realization process.  Obviously, any regulatory REQUIREMENTS related to the design of the device, labelling, testing, etc. are inputs to design controls.

I'm talking about the act of preparing and submitting a premarket notification/application and the interaction with the regulatory authority.  Assuming you've done a solid job of making sure the regulatory requirements were addressed during design controls, the resulting DHF documentation should be suitable for the countries defined at the beginning of the project and likely some "add-on" countries after the fact.  Furthermore, the country-specific registrations could be done shortly after V&V is complete or, in some cases, years after.

Why would you put the SUBMISSION process as part of design controls?  I am vehemently against this approach as I feel it would add unnecessary burden not only to the submissions, but to the design controls process.  Unless I was planning to submit in a new country with a requirement that would impact the existing DHF documentation, it just simply doesn't make sense to me for the submissions requiring even so much as a design review.

Also, have you ever used a regulatory clearance/approval as design validation?

Not sure if this is just simply out of my comfort zone and truly does have merit, or if it just simply doesn't make sense.

Looking forward to your input (and hopefully some confirmation that I'm not crazy)

Tina

In your current QS, where do you place regulatory SUBMISSIONS?  In all of my previous companies, submissions themselves were a parallel path to design controls within the "cradle to grave" product realization process.  Obviously, any regulatory REQUIREMENTS related to the design of the device, labelling, testing, etc. are inputs to design controls.

I'm talking about the act of preparing and submitting a premarket notification/application and the interaction with the regulatory authority.  Assuming you've done a solid job of making sure the regulatory requirements were addressed during design controls, the resulting DHF documentation should be suitable for the countries defined at the beginning of the project and likely some "add-on" countries after the fact.  Furthermore, the country-specific registrations could be done shortly after V&V is complete or, in some cases, years after.

Why would you put the SUBMISSION process as part of design controls?  I am vehemently against this approach as I feel it would add unnecessary burden not only to the submissions, but to the design controls process.  Unless I was planning to submit in a new country with a requirement that would impact the existing DHF documentation, it just simply doesn't make sense to me for the submissions requiring even so much as a design review.

Also, have you ever used a regulatory clearance/approval as design validation?

Not sure if this is just simply out of my comfort zone and truly does have merit, or if it just simply doesn't make sense.

Looking forward to your input (and hopefully some confirmation that I'm not crazy)

Tina

In your current QS, where do you place regulatory SUBMISSIONS?  In all of my previous companies, submissions themselves were a parallel path to design controls within the "cradle to grave" product realization process.  Obviously, any regulatory REQUIREMENTS related to the design of the device, labelling, testing, etc. are inputs to design controls.

I'm talking about the act of preparing and submitting a premarket notification/application and the interaction with the regulatory authority.  Assuming you've done a solid job of making sure the regulatory requirements were addressed during design controls, the resulting DHF documentation should be suitable for the countries defined at the beginning of the project and likely some "add-on" countries after the fact.  Furthermore, the country-specific registrations could be done shortly after V&V is complete or, in some cases, years after.

Why would you put the SUBMISSION process as part of design controls?  I am vehemently against this approach as I feel it would add unnecessary burden not only to the submissions, but to the design controls process.  Unless I was planning to submit in a new country with a requirement that would impact the existing DHF documentation, it just simply doesn't make sense to me for the submissions requiring even so much as a design review.

Also, have you ever used a regulatory clearance/approval as design validation?

Not sure if this is just simply out of my comfort zone and truly does have merit, or if it just simply doesn't make sense.

Looking forward to your input (and hopefully some confirmation that I'm not crazy)

Tina

In your current QS, where do you place regulatory SUBMISSIONS?  In all of my previous companies, submissions themselves were a parallel path to design controls within the "cradle to grave" product realization process.  Obviously, any regulatory REQUIREMENTS related to the design of the device, labelling, testing, etc. are inputs to design controls.

I'm talking about the act of preparing and submitting a premarket notification/application and the interaction with the regulatory authority.  Assuming you've done a solid job of making sure the regulatory requirements were addressed during design controls, the resulting DHF documentation should be suitable for the countries defined at the beginning of the project and likely some "add-on" countries after the fact.  Furthermore, the country-specific registrations could be done shortly after V&V is complete or, in some cases, years after.

Why would you put the SUBMISSION process as part of design controls?  I am vehemently against this approach as I feel it would add unnecessary burden not only to the submissions, but to the design controls process.  Unless I was planning to submit in a new country with a requirement that would impact the existing DHF documentation, it just simply doesn't make sense to me for the submissions requiring even so much as a design review.

Also, have you ever used a regulatory clearance/approval as design validation?

Not sure if this is just simply out of my comfort zone and truly does have merit, or if it just simply doesn't make sense.

Looking forward to your input (and hopefully some confirmation that I'm not crazy)

Tina

In your current QS, where do you place regulatory SUBMISSIONS?  In all of my previous companies, submissions themselves were a parallel path to design controls within the "cradle to grave" product realization process.  Obviously, any regulatory REQUIREMENTS related to the design of the device, labelling, testing, etc. are inputs to design controls.

I'm talking about the act of preparing and submitting a premarket notification/application and the interaction with the regulatory authority.  Assuming you've done a solid job of making sure the regulatory requirements were addressed during design controls, the resulting DHF documentation should be suitable for the countries defined at the beginning of the project and likely some "add-on" countries after the fact.  Furthermore, the country-specific registrations could be done shortly after V&V is complete or, in some cases, years after.

Why would you put the SUBMISSION process as part of design controls?  I am vehemently against this approach as I feel it would add unnecessary burden not only to the submissions, but to the design controls process.  Unless I was planning to submit in a new country with a requirement that would impact the existing DHF documentation, it just simply doesn't make sense to me for the submissions requiring even so much as a design review.

Also, have you ever used a regulatory clearance/approval as design validation?

Not sure if this is just simply out of my comfort zone and truly does have merit, or if it just simply doesn't make sense.

Looking forward to your input (and hopefully some confirmation that I'm not crazy)

Tina

In your current QS, where do you place regulatory SUBMISSIONS?  In all of my previous companies, submissions themselves were a parallel path to design controls within the "cradle to grave" product realization process.  Obviously, any regulatory REQUIREMENTS related to the design of the device, labelling, testing, etc. are inputs to design controls.

I'm talking about the act of preparing and submitting a premarket notification/application and the interaction with the regulatory authority.  Assuming you've done a solid job of making sure the regulatory requirements were addressed during design controls, the resulting DHF documentation should be suitable for the countries defined at the beginning of the project and likely some "add-on" countries after the fact.  Furthermore, the country-specific registrations could be done shortly after V&V is complete or, in some cases, years after.

Why would you put the SUBMISSION process as part of design controls?  I am vehemently against this approach as I feel it would add unnecessary burden not only to the submissions, but to the design controls process.  Unless I was planning to submit in a new country with a requirement that would impact the existing DHF documentation, it just simply doesn't make sense to me for the submissions requiring even so much as a design review.

Also, have you ever used a regulatory clearance/approval as design validation?

Not sure if this is just simply out of my comfort zone and truly does have merit, or if it just simply doesn't make sense.

Looking forward to your input (and hopefully some confirmation that I'm not crazy)

Tina

In your current QS, where do you place regulatory SUBMISSIONS?  In all of my previous companies, submissions themselves were a parallel path to design controls within the "cradle to grave" product realization process.  Obviously, any regulatory REQUIREMENTS related to the design of the device, labelling, testing, etc. are inputs to design controls.

I'm talking about the act of preparing and submitting a premarket notification/application and the interaction with the regulatory authority.  Assuming you've done a solid job of making sure the regulatory requirements were addressed during design controls, the resulting DHF documentation should be suitable for the countries defined at the beginning of the project and likely some "add-on" countries after the fact.  Furthermore, the country-specific registrations could be done shortly after V&V is complete or, in some cases, years after.

Why would you put the SUBMISSION process as part of design controls?  I am vehemently against this approach as I feel it would add unnecessary burden not only to the submissions, but to the design controls process.  Unless I was planning to submit in a new country with a requirement that would impact the existing DHF documentation, it just simply doesn't make sense to me for the submissions requiring even so much as a design review.

Also, have you ever used a regulatory clearance/approval as design validation?

Not sure if this is just simply out of my comfort zone and truly does have merit, or if it just simply doesn't make sense.

Looking forward to your input (and hopefully some confirmation that I'm not crazy)

Tina

In your current QS, where do you place regulatory SUBMISSIONS?  In all of my previous companies, submissions themselves were a parallel path to design controls within the "cradle to grave" product realization process.  Obviously, any regulatory REQUIREMENTS related to the design of the device, labelling, testing, etc. are inputs to design controls.

I'm talking about the act of preparing and submitting a premarket notification/application and the interaction with the regulatory authority.  Assuming you've done a solid job of making sure the regulatory requirements were addressed during design controls, the resulting DHF documentation should be suitable for the countries defined at the beginning of the project and likely some "add-on" countries after the fact.  Furthermore, the country-specific registrations could be done shortly after V&V is complete or, in some cases, years after.

Why would you put the SUBMISSION process as part of design controls?  I am vehemently against this approach as I feel it would add unnecessary burden not only to the submissions, but to the design controls process.  Unless I was planning to submit in a new country with a requirement that would impact the existing DHF documentation, it just simply doesn't make sense to me for the submissions requiring even so much as a design review.

Also, have you ever used a regulatory clearance/approval as design validation?

Not sure if this is just simply out of my comfort zone and truly does have merit, or if it just simply doesn't make sense.

Looking forward to your input (and hopefully some confirmation that I'm not crazy)

Tina

In your current QS, where do you place regulatory SUBMISSIONS?  In all of my previous companies, submissions themselves were a parallel path to design controls within the "cradle to grave" product realization process.  Obviously, any regulatory REQUIREMENTS related to the design of the device, labelling, testing, etc. are inputs to design controls.

I'm talking about the act of preparing and submitting a premarket notification/application and the interaction with the regulatory authority.  Assuming you've done a solid job of making sure the regulatory requirements were addressed during design controls, the resulting DHF documentation should be suitable for the countries defined at the beginning of the project and likely some "add-on" countries after the fact.  Furthermore, the country-specific registrations could be done shortly after V&V is complete or, in some cases, years after.

Why would you put the SUBMISSION process as part of design controls?  I am vehemently against this approach as I feel it would add unnecessary burden not only to the submissions, but to the design controls process.  Unless I was planning to submit in a new country with a requirement that would impact the existing DHF documentation, it just simply doesn't make sense to me for the submissions requiring even so much as a design review.

Also, have you ever used a regulatory clearance/approval as design validation?

Not sure if this is just simply out of my comfort zone and truly does have merit, or if it just simply doesn't make sense.

Looking forward to your input (and hopefully some confirmation that I'm not crazy)

Tina

In your current QS, where do you place regulatory SUBMISSIONS?  In all of my previous companies, submissions themselves were a parallel path to design controls within the "cradle to grave" product realization process.  Obviously, any regulatory REQUIREMENTS related to the design of the device, labelling, testing, etc. are inputs to design controls.

I'm talking about the act of preparing and submitting a premarket notification/application and the interaction with the regulatory authority.  Assuming you've done a solid job of making sure the regulatory requirements were addressed during design controls, the resulting DHF documentation should be suitable for the countries defined at the beginning of the project and likely some "add-on" countries after the fact.  Furthermore, the country-specific registrations could be done shortly after V&V is complete or, in some cases, years after.

Why would you put the SUBMISSION process as part of design controls?  I am vehemently against this approach as I feel it would add unnecessary burden not only to the submissions, but to the design controls process.  Unless I was planning to submit in a new country with a requirement that would impact the existing DHF documentation, it just simply doesn't make sense to me for the submissions requiring even so much as a design review.

Also, have you ever used a regulatory clearance/approval as design validation?

Not sure if this is just simply out of my comfort zone and truly does have merit, or if it just simply doesn't make sense.

Looking forward to your input (and hopefully some confirmation that I'm not crazy)

Tina

In your current QS, where do you place regulatory SUBMISSIONS?  In all of my previous companies, submissions themselves were a parallel path to design controls within the "cradle to grave" product realization process.  Obviously, any regulatory REQUIREMENTS related to the design of the device, labelling, testing, etc. are inputs to design controls.

I'm talking about the act of preparing and submitting a premarket notification/application and the interaction with the regulatory authority.  Assuming you've done a solid job of making sure the regulatory requirements were addressed during design controls, the resulting DHF documentation should be suitable for the countries defined at the beginning of the project and likely some "add-on" countries after the fact.  Furthermore, the country-specific registrations could be done shortly after V&V is complete or, in some cases, years after.

Why would you put the SUBMISSION process as part of design controls?  I am vehemently against this approach as I feel it would add unnecessary burden not only to the submissions, but to the design controls process.  Unless I was planning to submit in a new country with a requirement that would impact the existing DHF documentation, it just simply doesn't make sense to me for the submissions requiring even so much as a design review.

Also, have you ever used a regulatory clearance/approval as design validation?

Not sure if this is just simply out of my comfort zone and truly does have merit, or if it just simply doesn't make sense.

Looking forward to your input (and hopefully some confirmation that I'm not crazy)

Tina

In your current QS, where do you place regulatory SUBMISSIONS?  In all of my previous companies, submissions themselves were a parallel path to design controls within the "cradle to grave" product realization process.  Obviously, any regulatory REQUIREMENTS related to the design of the device, labelling, testing, etc. are inputs to design controls.

I'm talking about the act of preparing and submitting a premarket notification/application and the interaction with the regulatory authority.  Assuming you've done a solid job of making sure the regulatory requirements were addressed during design controls, the resulting DHF documentation should be suitable for the countries defined at the beginning of the project and likely some "add-on" countries after the fact.  Furthermore, the country-specific registrations could be done shortly after V&V is complete or, in some cases, years after.

Why would you put the SUBMISSION process as part of design controls?  I am vehemently against this approach as I feel it would add unnecessary burden not only to the submissions, but to the design controls process.  Unless I was planning to submit in a new country with a requirement that would impact the existing DHF documentation, it just simply doesn't make sense to me for the submissions requiring even so much as a design review.

Also, have you ever used a regulatory clearance/approval as design validation?

Not sure if this is just simply out of my comfort zone and truly does have merit, or if it just simply doesn't make sense.

Looking forward to your input (and hopefully some confirmation that I'm not crazy)

Tina