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Medical Devices (21 CFR Part 820)

Medical Devices (21 CFR Part 820)

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  1. MarkMeer

    Justifying NOT following an FDA guidance?

    MarkMeer, Jan 5, 2016
    Replies:
    12
    Views:
    2,637
    MarkMeer
    Jan 9, 2016
  2. MKenn

    Are Capability Studies a regulatory requirement ?

    MKenn, Mar 3, 2017
    Replies:
    10
    Views:
    2,298
    Vintage Goose
    Mar 9, 2017
  3. QAengineer13

    Design Reviews

    QAengineer13, Dec 18, 2015
    Replies:
    10
    Views:
    2,006
    MCW8888
    Dec 24, 2015
  4. Abdullah

    Assembly and Packaging areas separation ??!!!

    Abdullah, Dec 22, 2015
    Replies:
    9
    Views:
    1,860
    Pads38
    Jan 4, 2016
  5. Lee G.

    Quality Plan (FDA) requirement

    Lee G., Aug 21, 2015
    Replies:
    7
    Views:
    2,557
    Marcelo Antunes
    Aug 27, 2015
  6. Tiffany Detzel

    Supplier Audit Question

    Tiffany Detzel, Nov 8, 2022
    Replies:
    6
    Views:
    2,811
    andic
    Nov 9, 2022
  7. QAengineer13

    Regulatory Document Structure For NPI

    QAengineer13, Feb 23, 2016
    Replies:
    6
    Views:
    1,903
    QAengineer13
    Feb 25, 2016
  8. Dave14867

    Excel or Access, which is better to use

    Dave14867, Apr 14, 2018
    Replies:
    5
    Views:
    1,445
    Dave14867
    Apr 18, 2018
  9. dosumi

    820.40 document controls

    dosumi, Aug 7, 2015
    Replies:
    5
    Views:
    2,002
    Gert Sørensen
    Sep 8, 2015
  10. Daliane

    Comply with GMP 21 CFR (820) / excisting ISO 9001 and ISO 13485

    Daliane, Oct 30, 2015
    Replies:
    4
    Views:
    1,620
    Daliane
    Nov 9, 2015
  11. Gözde Aktener

    Life time of product for a biodegradable device

    Gözde Aktener, Aug 31, 2018
    Replies:
    3
    Views:
    2,547
    Terry Spirk
    Oct 13, 2020
  12. siwing

    QC vs. QA on product release process

    siwing, Apr 4, 2020
    Replies:
    3
    Views:
    1,585
    yodon
    Apr 4, 2020
  13. Emilia

    "Catch up" 510k

    Emilia, Sep 13, 2016
    Replies:
    3
    Views:
    2,474
    Al Weisenborn
    Feb 27, 2018
  14. QA Bee

    Real Time Stability

    QA Bee, Jan 14, 2016
    Replies:
    3
    Views:
    1,870
    Ronen E
    Jan 18, 2016
  15. Ronen E

    2015 Annual FDA Medical Device Quality System Data

    Ronen E, Mar 17, 2016
    Replies:
    2
    Views:
    1,767
    Ronen E
    Mar 17, 2016
  16. Daliane

    How to implement 820.20 (d) “ Quality planning“?

    Daliane, Feb 8, 2016
    Replies:
    2
    Views:
    5,463
    Daliane
    Feb 12, 2016
  17. Daliane

    CTD only for pharmaceutical products or also for IVD required?

    Daliane, Nov 11, 2015
    Replies:
    2
    Views:
    1,072
    Vintage Goose
    Nov 12, 2015
  18. qu1nn

    Veterinary - Medical Device - Weigh Scale - GMP requirement?

    qu1nn, Sep 17, 2015
    Replies:
    2
    Views:
    1,118
    Ronen E
    Sep 19, 2015
  19. rohit16

    Anyone know where you can sell medical devices?

    rohit16, Dec 21, 2020
    Replies:
    1
    Views:
    3,400
    yodon
    Dec 21, 2020
  20. John Thacher

    DMR Maintenance and Servicing Procedures Clarification 820.181

    John Thacher, Dec 17, 2020
    Replies:
    1
    Views:
    569
    yodon
    Dec 17, 2020
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