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Medical Devices (21 CFR Part 820)

Medical Devices (21 CFR Part 820)

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  1. Emilia

    "Catch up" 510k

    Emilia, Sep 13, 2016
    Replies:
    3
    Views:
    2,481
    Al Weisenborn
    Feb 27, 2018
  2. Ronen E

    2015 Annual FDA Medical Device Quality System Data

    Ronen E, Mar 17, 2016
    Replies:
    2
    Views:
    1,769
    Ronen E
    Mar 17, 2016
  3. dosumi

    820.40 document controls

    dosumi, Aug 7, 2015
    Replies:
    5
    Views:
    2,008
    Gert Sørensen
    Sep 8, 2015
  4. rohit16

    Anyone know where you can sell medical devices?

    rohit16, Dec 21, 2020
    Replies:
    1
    Views:
    3,402
    yodon
    Dec 21, 2020
  5. MKenn

    Are Capability Studies a regulatory requirement ?

    MKenn, Mar 3, 2017
    Replies:
    10
    Views:
    2,310
    Vintage Goose
    Mar 9, 2017
  6. Abdullah

    Assembly and Packaging areas separation ??!!!

    Abdullah, Dec 22, 2015
    Replies:
    9
    Views:
    1,870
    Pads38
    Jan 4, 2016
  7. subbash

    Clarification regarding tests in IEC 60601-2-25

    subbash, Aug 8, 2018
    Replies:
    0
    Views:
    946
    subbash
    Aug 8, 2018
  8. Nadine

    Combination Products

    Nadine, Nov 9, 2015
    Replies:
    0
    Views:
    837
    Nadine
    Nov 9, 2015
  9. Daliane

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

    Daliane, Oct 30, 2015
    Replies:
    4
    Views:
    1,625
    Daliane
    Nov 9, 2015
  10. 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
  11. Vintage Goose

    De Novo Route

    Vintage Goose, Feb 2, 2016
    Replies:
    0
    Views:
    962
    Vintage Goose
    Feb 2, 2016
  12. talent.acquiring

    Design control requirements of Part 820

    talent.acquiring, Feb 5, 2019
    Replies:
    1
    Views:
    2,266
    yodon
    Feb 6, 2019
  13. QAengineer13

    Design Reviews

    QAengineer13, Dec 18, 2015
    Replies:
    10
    Views:
    2,015
    MCW8888
    Dec 24, 2015
  14. John Thacher

    DMR Maintenance and Servicing Procedures Clarification 820.181

    John Thacher, Dec 17, 2020
    Replies:
    1
    Views:
    577
    yodon
    Dec 17, 2020
  15. Jo Campbell

    EtO Sterilisation Validation

    Jo Campbell, Jan 5, 2016
    Replies:
    1
    Views:
    1,170
    Ronen E
    Jan 5, 2016
  16. Dave14867

    Excel or Access, which is better to use

    Dave14867, Apr 14, 2018
    Replies:
    5
    Views:
    1,447
    Dave14867
    Apr 18, 2018
  17. Shaun Me

    Exporting from the UK to Canada

    Shaun Me, Jun 1, 2018
    Replies:
    1
    Views:
    1,045
    yodon
    Jun 1, 2018
  18. Daliane

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

    Daliane, Feb 8, 2016
    Replies:
    2
    Views:
    5,471
    Daliane
    Feb 12, 2016
  19. MarkMeer

    Justifying NOT following an FDA guidance?

    MarkMeer, Jan 5, 2016
    Replies:
    12
    Views:
    2,649
    MarkMeer
    Jan 9, 2016
  20. Gözde Aktener

    Life time of product for a biodegradable device

    Gözde Aktener, Aug 31, 2018
    Replies:
    3
    Views:
    2,551
    Terry Spirk
    Oct 13, 2020
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