Post Market Surveillance

What are the best-practices for Medical Device & IVD companies once a product has reached the market?

  • 3 Topics
  • 9 Replies

3 Topics

ashkonrasooli
ashkonrasooliNew Participant
posted in Post Market Surveillance

Complaint Handling Requirements

Community, With complaint handling training, is there a line beyond which you consider a supplier / contractor too removed to get training? For example, you may have a contractor with limited scope of on-demand services they provide to the manufacturer with very low likelihood of them ever becoming aware of a complaint. Is the manufacturer still required to train this individual / supplier? Looking for the least burdensome yet compliant approach here.

4
ashkonrasooli
2 months ago
D
damini_agarwalNew Participant
posted in Post Market Surveillance

How to stay on top of changes in the regulatory landscape?

As a small medical technology company, with a small team and no single person dedicated full time to studying the regulatory landscape, what are some easy ways to stay abreast with changes so that they don’t sneak up on you? Especially pertaining to ISO, IEC standards and international markets, are there good blogs or forums one can follow?

5
bjohnson
7 months ago
georgezack
georgezackNew Participant
posted in Post Market Surveillance

Warning Letters of recent for devices

All all of you gurus, etcFor the second straight week we have had a warning letter posted from CDRH.  There have actually been 3 in the last two weeks.  This may not seem like a lot but when you consider that there has been a general lack of warning letters, I see it as a noticeable uptick.I have been cross posting over in Linkedin on these warning letters, asking these questions:what can we learn from these? are there any findings from these that we think would also be findings someday against the proposed QSMR rule? why do we see the Agency say so many times that the response from the receiving firm was considered inadequate?Interested in hearing opinions on these for the recent warning letters, other items we should learn from them or any other “hot takes.”ThanksGZ

0
georgezack
10 months ago

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