As a consultant I work with a number of different companies, different Notified Bodies (NBs) and ultimately different Competent Authorities (CAs) and I have seen little consistency of requirement.
There are a lot of legal difficulties in many jurisdictions about including "third-person" CVs, even if you a document specific release from the person, and as pointed out a general CV does not always show the specific clinical expertese a NB requires.
My experience is also that different national CAs "download" different requirements and expectations onto the NBs which they monitor. Currently, we would expect to have three or four people co-authour and/or approve the clinical evaluation (or part of it), typically this might be:
- the clinical author or researcher who found the information and wrote the draft
- an engineer or materials scientist from the manufacturer who can address physical properties of materials and processes
- a senior nurse skilled in using the device
- a consultant surgeon or head of specialization at a university
and ask each to write a one page summary of why they are experienced or sufficently qualified to participate in the clinical evaluation.
I do appreciate this can still be through to fall short of objective evidence, but it is the best we feel we can do and so far has been pretty universally accepted.
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Neil Armstrong
CEO
MeddiQuest Ltd.
Cambridgeshire
United Kingdom
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