What to be careful about/focus on when doing a Technical File review


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Hi everyone!
I would like to get some suggestions or feedback on what to be careful about/focus on when doing a technical file review.
I will be doing a technical file review (my first one) of a Class I medical device product soon and since I am not experienced in this, I would like to hear your opinions on how to handle the whole process, how to make comments/give feedback after the review, etc.
Any input or experience/thoughts on this matter will be helpful to me.
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A difficult question to answer succinctly. Obviously, compliance to (presuming MDR) Annex I & II (and III if it's a product that's been in the market).

Some things that I've seen as "got'chas" would include:
  • is each referenced standard the latest revision (and any data showing compliance is to that revision)?
  • will the data be considered reliable; e.g., was it collected (or assessed) by an accredited lab or was it compiled by Joe's Garage and Tire shop? (I had one NB reject an assertion of compliance to 62304 because it was self-declared, not assessed by an accredited lab - they said I could either get a lab to do it or they would assess it for an extra charge... sheesh).
  • are you referencing the latest harmonized standards?
  • is the data complete and sufficient to demonstrate compliance (often hard to know!)
  • does the data provided actually demonstrate compliance?
  • do you actually support your benefit-risk analysis or is it just hand-waving? (Yes, that's rather subjective but a strong case IS needed.)
That's all that comes to mind right now. Is this what you're looking for? Maybe others will chime in with their experiences.


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I meant to what standard will you be auditing. I think yodon is probably right in assuming MDR, but I would have to add that I've seen way too many audits by amateurs (more the organization than the individual auditor, who often knew better) that were essentially a waste of time, due to a lack of standard. (GMP, GLP, GCP, etc....these are all just concepts; you can't usefully audit to a concept.)

You are getting hands-on training in the review of tech files?
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