AMA on MDSAP


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This week we’ve invited @Danny Kroo from Docusys for an exclusive AMA (ask me anything) session with the community concerning the topic of the Medical Device Single Audit Program (MDSAP.)

We hope you find this session informative and engaging!

If you have any feedback or suggestions, send a message directly to @Etienne and let us know!

 

 

Jaymie Hu 4 months ago

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Has maybe Danny Kroo a super bombproof question list, which is usable for preparation period of a legal manufacturer company, when a new medical device is intended to brought to the USA and European market as well?

I mean: if all the requested documents are on the list, and company answers: yes I have got them, the company shouldn't have big difficulties at the auditing and certificating period.

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We’re just focused on TGA right now (australia) 

Is there a considerable more amount of work to pursue MDSAP ? Is there a table or something out there that shows the different things required for the different countries? 

To go straight through TGA, it sounds like it will be around $30,000. Does it make sense to do MDSAP instead? We're still in the early stages and a small (less than 5 person) team.

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If we pursue an MDSAP certification, will we also get a 13485 certification? Or is 13485 not included/required for MDSAP?

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Thank you for putting this on! I won’t be able to attend, but I can’t wait to hear more about this topic. Any links or guides would be extremely helpful as we are very confused on how to proceed!

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How does an MDSAP audit differ from an FDA inspection or ISO13485 audit?

Aside from a broader set of requirements due to multiple countries, do you have recommendations on how we as companies should approach MDSAP audits differently than other audits/inspections?

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If a manufacturer is only planning on selling in a couple of the MDSAP countries, can the scope of the audit be limited to only cover the regulations for those countries?

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Can a manufacturer have an MDSAP and ISO 13485 audit conducted at the same time?

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Who should get MDSAP certified. I know where/when it's required. But at what point should we pursue it? Early? Later? When is the right time?

For companies using contract manufacturers, can quality agreements be used to address the requirements for production and service controls?

Userlevel 3

Which, if any, additional SOPs would a manufacturer need for MDSAP that aren’t required for ISO 13485?

I understand there is a new MDSAP Document No.: MDSAP AU P0037.001, which was effective September 2021, which provides guidelines for the use of the document “GHTF/SG3/N19:2012:  Quality management system - Medical devices - Nonconformity Grading System for Regulatory Purposes and Information Exchange for grading nonconformities resulting from MDSAP audits”. What is the purpose of this new document and does it introduce any new requirements / approaches to grading NCs?

I am subscribed to updates to the FDA MDSAP page to get updates, but I never receive any! (e.g. I didn’t receive the new MDSAP AU P0037.001 or the new Audit Policy MDSAP AUDIT P0002.007). Is there an MDSAP organisation that I can subscribe to for updates. or at least review to see what’s new?

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Can a manufacturer have an MDSAP and ISO 13485 audit conducted at the same time?

Yes, it is a “combined audit” - both audits at the same time.

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Which, if any, additional SOPs would a manufacturer need for MDSAP that aren’t required for ISO 13485?

There are not really additional SOPs, but you have to change many (a lot) of your SOPs to add country specific required “verbiage” and references to each MDSAP country’s regulations.

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How does an MDSAP audit differ from an FDA inspection or ISO13485 audit?

Aside from a broader set of requirements due to multiple countries, do you have recommendations on how we as companies should approach MDSAP audits differently than other audits/inspections?

One key thing that I encountered - The 13485 and MDSAP audits are so extensive that the auditor made us break our team into two groups and had two audit sessions going on at the same time. This caused us to need a LOT more coordination. My team had to step out of the audit room to confer with each other once and a while.

ALSO, the MDSAP audit is more timed - time was allocated to each section and made the process more tricky in planning the timing. You had to get back with answers/evidence faster.

AND, the results of the audit are shared with all country’s regulatory agencies, INCLUDING THE FDA. This is not true for a straight 13485 audit. Make sure that you are prepared for this, in case you have major findings (4s, 5s).

Are there any significant changes MDSAP certified companies should be aware of in the updated MDSAP Audit Approach P0002.007 from version 006 to 007?

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Who should get MDSAP certified. I know where/when it's required. But at what point should we pursue it? Early? Later? When is the right time?

Depends when you need it. It will take you months to get your documents updated. Also, not all notified bodies can audit for MDSAP, so scheduling can be pretty far out.

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Is there anything “MDSAP” specific about SaMD?

Userlevel 1

Has maybe Danny Kroo a super bombproof question list, which is usable for preparation period of a legal manufacturer company, when a new medical device is intended to brought to the USA and European market as well?

I mean: if all the requested documents are on the list, and company answers: yes I have got them, the company shouldn't have big difficulties at the auditing and certificating period.

There are checklists that have been established for both USA (21 CFR 820) and Europe (EU MDR).

If you are able to address all the requirements from these checklists, you should not have any major issues during the audit.

However for MDSAP, it can be helpful for your internal audit to simulate the MDSAP requirements by someone who is knowledgeable about MDSAP since the questions are different and it gives the process owners a chance to familiarize themselves with the questions.

 

 

Userlevel 1

I understand there is a new MDSAP Document No.: MDSAP AU P0037.001, which was effective September 2021, which provides guidelines for the use of the document “GHTF/SG3/N19:2012:  Quality management system - Medical devices - Nonconformity Grading System for Regulatory Purposes and Information Exchange for grading nonconformities resulting from MDSAP audits”. What is the purpose of this new document and does it introduce any new requirements / approaches to grading NCs?

This document explains the grading system that is used in the MDSAP audit and how to write nonconformities.

It explains the difference between direct QMS impact and indirect QMS impact. 

Clauses 4.1 to 6.3 (except for 4.2.3) are considered indirect and clauses 6.4 to 8.5 (except 8.2.4) are direct.

Userlevel 1

Can a manufacturer have an MDSAP and ISO 13485 audit conducted at the same time?

Yes, it can be done

Userlevel 1

Is there anything “MDSAP” specific about SaMD?

There is no specific mention of SaMD but Task 12 of Chapter 5 (Design & Development) covers software development.

I would predict that SaMD will be added in future updates.

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If a manufacturer is only planning on selling in a couple of the MDSAP countries, can the scope of the audit be limited to only cover the regulations for those countries?

Yes it will cover the MDSAP countries that you are distributing your device,

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If we pursue an MDSAP certification, will we also get a 13485 certification? Or is 13485 not included/required for MDSAP?

Yes your certificate will mention ISO 13485:2016,  “MDSAP”, scope of certification and the countries where you can distribute.

All done in one audit.

Userlevel 1

We’re just focused on TGA right now (australia) 

Is there a considerable more amount of work to pursue MDSAP ? Is there a table or something out there that shows the different things required for the different countries? 

To go straight through TGA, it sounds like it will be around $30,000. Does it make sense to do MDSAP instead? We're still in the early stages and a small (less than 5 person) team.

If you are interested in selling to Canada, MDSAP is the way to go.

Otherwise I would recommend going directly to TGA since there may be less delays and may cost less.

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