post market activities (misc)

  1. Marcelo Antunes

    Medical Device News FDA's Policies and Procedures Should Better Address Postmarket Cybersecurity Risk to Medical Devices

    Office of Inspector General of the U.S. Department of Health & Human Services (HHS) - The Food and Drug Administration's Policies and Procedures Should Better Address Postmarket Cybersecurity Risk to Medical Devices Full Report - https://oig.hhs.gov/oas/reports/region18/181630530.pdf
  2. SK13485

    What are Regional or National Device Registries for Medical Devices?

    Registry as defined by EU is as follows: An organized system that continuously and consistently collects relevant data in conjunction with routine clinical care, evaluates meaningful outcomes, and comprehensively covers the population defined by exposure to particular device(s) at a reasonably...
  3. E

    On going Stability for IVDs

    Don't know if this is the right forum. Is there any requirement for ongoing or post-approval stability for IVDs? Looking for what is the requirement through FDA and EU? Thanks
  4. T

    Orthopaedic Registries - Bone fracture implants (e.g. screws. plates,etc)

    Hello all :bigwave:, I am part of the post market surveillance team for a medical device company in Switzerland as well as new in this area. We want to implement a more active PMS and thus, I wanted to ask if any of you has had experience with orthopaedic registries. As industry can we have...
  5. Marcelo Antunes

    AAMI draft report - Postmarket Risk Management

    AAMI draft for comment - Postmarket Risk Management: A Framework for Incorporating Benefit-Risk Assessments into Postmarket Decisions - See more at: http://www.aami.org/newsviews/newsdetail.aspx?ItemNumber=3685#sthash.hoxgwcDl.dpuf
  6. S

    Verification and Validation of Post Market Design Change

    Hello, My question is about V&V of parts that get iterated past revision A, how does one maintain traceability? We have a part in stock that is rev B. R&D is proposing changes to part and ordered the parts. These parts were not accepted through the receiving process instead were delivered...
Top Bottom