How can we demonstrate to MDSAP auditors that we have the requisite training

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mihzago

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#2
I don't think you need training on MDSAP itself, rather you need training on the QMS and regulatory requirements covered by the MDSAP.
So you need to have training on ISO13485 and regulatory requirements of all relevant countries within the scope of your MDSAP audit, for example in the US I would include 21CFR 801, 803, 806, 807, 820, etc.
 

shimonv

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#3
I agree with mihzago. MDSAP does not introduce new regulatory requirements; what it does is consolidates requirements from five different countries into one auditing program.

The three big things about it in my mind are:
1. It's a long audit.. meaning you can expect more findings.
2. The MDSAP audit follows the process approach which is different from the EU/ISO audits.
3. For some manufactures it would be the first time someone evaluated their compliance with FDA requirements.

It would be nice to do a general training on the subject. A good source of information is the FDA website

-Shimon
 
#5
Our consultant recommended we compile a document with the main regulations for all five countries, plus references to dig deeper. Then have all relevant folks be trained based on that document.

We already have extensive training on our QMS for everyone so that wasn't an issue.
 
#6
Thanks. That's very useful information. However, how do we effectively demonstrate competence? Is there a place where we can take tests ?
Simply watching webinars and reading the regulations shows we've done our training, but doesn't demonstrate effectiveness of training.

Thanks.
 

Mark Meer

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#7
...how do we effectively demonstrate competence? Is there a place where we can take tests ?
Simply watching webinars and reading the regulations shows we've done our training, but doesn't demonstrate effectiveness of training.
Formal tests, IMO, are a poor gauge of competence. Even if there were such tests, they wouldn't necessarily map on to your requirements. If you need a test you'd want to develop one yourself to align with your requirements, and incorporate into your training program.

In my experience, however, auditors wouldn't care about such tests. What they are looking for is evidence of non-competence. They will ask personnel some questions to verify that they've got a good grasp of their responsibilities and the process requirements they oversee, and check things like NCs and CAPA investigations to see if there is any evidence of insufficient training.

If:
1. you've got training/qualification records (according to whatever criteria you've established)
2. you're confident in your personnel's competence (their ability to answer auditor questions)
3. you've got a system in place to monitor performance; and
4. there have been no problems that call into question training/competence,
...then I'd say that's demonstrative that your training is effective.
 

Edward Reesor

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#8
The EU MDR has a section on what their auditors require to be seen as "competent":
""Clause 6.4 introduces specific requirements for the expertise and experience of CER authors and evaluators, including a relevant higher education degree and five years’ related professional experience, or ten years’ professional experience if a degree is not considered a prerequisite for the task. Deviations from these requirements should be documented and duly justified".
 

Edward Reesor

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#10
MDR (Part I). Page 30/336, Article 15, part 1.

Article 15
Person responsible for regulatory compliance

1.Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices.
The requisite expertise shall be demonstrated by either of the following qualifications: (a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices;
(b) four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
Without prejudice to national provisions regarding professional qualifications, manufacturers of custom-made devices may demonstrate the requisite expertise referred to in the first subparagraph by having at least two years of professional experience within a relevant field of manufacturing.
 
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