Stacey, all of your observations are correct, but, based on my understanding of the MDSAP program, I don't see them as drawbacks of the MDSAP, but as drawbacks of pursuing more than ISO 13485 certification, MDSAP or no MDSAP.
If you only need ISO 13485 certification to sell in your markets, then I can't see any reason to use MDSAP. It is designed for companies that want multiple regulatory audits because they want to sell in markets that require multiple regulatory audits, not just ISO 13485 certification.
1) The application process is much more detailed than ISO 13485 because the ISO 13485 application is only for an ISO 13485 audit, while the application process for MDSAP is for multiple audits. The question is whether it is more time and cost effective to arrange for a single MDSAP audit than for these multiple audits, not whether it is more time and cost effective to arrange for any given single audit.
2) The audits will be longer, more complex, and costly than ISO 13485 audits, but not more so than the combination of audits you select. Under MDAPS, you can choose to be simultaneously audited to, for example, FDA, ANVISA, and MO 169 requirements, you can choose to forego MDSAP, and do each audit separately.
3-4) Yes, I think the multijurisdictional transparency question is the most interesting one. I asked about it in Vancouver. Actually, I limited my question to the fact that FDA practices more transparency than any other jurisdiction in the world, and that FDA has said it will treat MDSAP reports like is own EIRs (along with, presumably, any resulting warning letters, consent decrees, etc). If so, this may come as shock to companies who are used to having their regulatory dirty laundry safely hidden from public scrutiny. Based on the responses, I concluded that no one has it thus far, nor is anyone eager to do so. That said, I don't see it as a drawback/con that is likely to increase over time, which was the focus of Harsh's question. If it is a drawback/con of the MDSAP today, it will probably be the same drawback/con in 20 years, too.
5) If you need to be audited for compliance in 6 jurisdictions, then the auditor(s) will have to be trained in the requirements of all 6 jurisdictions, whether there is a MDSAP program or not. There should be no requirement for a MDSAP auditor who conducting an MDSAP audit covering only 3 jurisdictions to be trained in anything but the requirements for those 3 jurisdictions. If that is a requirement, that is a problem, especially during this early adoption phase, when trained auditors are at a premium. (I count only 5 jurisdictions participating in the MDSAP program?)
6) This comment puzzles me. I just learned that Canada recently adopted ISO 13485 as its QSR-equivalent. I can't imagine any company that is so globally oriented that it would choose to use MDSAP wouldn't also have ISO 13485 certification. I think this means that, for these companies, instead of having to do their ISO audit as a separate audit, they can now include it in their MDSAP audit, but I'm not sure about that. I also think that, until Health Canada adopted ISO 13485 as its QSR-equivalent, you couldn't include ISO 13485 in your MDSAP audit, so perhaps Health Canada's goal was to let ISO 13485 in the back door, so to speak.
You seem to be looking at MDSAP as an alternative to ISO 13485 certification, which I don't think it is, nor that it was ever intended to be. But, again, this is MDSAP as I understand it, and I'm just following it as a point of interest, not because I'm involved in these kinds of audits. Perhaps others here can clarify some misunderstanding I have, and which would shed a different light.
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com------------------------------
Original Message:
Sent: 30-Apr-2017 13:55
From: Stacey Henning
Subject: Cons of MDSAP
MDSAP CONS:
1) Application Process much more detailed than ISO 13485 (including providing Product lists, registration and licence lists, flow charts and approved supplier and significant subcontractor lists)
2) Audits will be longer, more complex and costly than standard ISO 13485 audits. - You be having a simultaneous audit to ISO 13485, 21 CFR 820, MO 169 (Japan), ANVISA, Canadian SOR, and Australian Regulations.
3) MDSAP audits can open the manufacturer's management Review and Internal Audit files to these Competent Authorities.
4) A finding in product realization section carries 3 points. If this product has shipped, that's another point. 5 points and all regulatory authorities get a copy of the audit report - and may come in with a "For Cause" audit themselves.
5) Internal Auditors need to be MDSAP qualified - that's learning 6 regulations. These Internal Audits must occur at the locations prior to the external MDSAP audit.
6) Cost and effort of MDSAP may force many small manufacturer's out of the Canadian Market
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Stacey Henning
United States
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Original Message:
Sent: 27-Apr-2017 14:27
From: Harsh Raja
Subject: Cons of MDSAP
Hello Everyone,
As we know MDSAP (Medical Device Single Audit Program) is a single audit used in the lieu of the multiple audits by reducing the number of audits and optimizing the time and resources. Is anyone of opinion that MDSAP program can have disadvantages over time?
Any relevant articles or websites will also do.
Thank you.
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Harsh Raja,
MSRA candidate,
Northeastern University,
Boston MA
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