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Medical Devices (21 CFR Part 820)

Medical Devices (21 CFR Part 820)

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  1. Tiffany Detzel

    Supplier Audit Question

    Tiffany Detzel, Nov 8, 2022
    Replies:
    6
    Views:
    2,765
    andic
    Nov 9, 2022
  2. rohit16

    Anyone know where you can sell medical devices?

    rohit16, Dec 21, 2020
    Replies:
    1
    Views:
    3,396
    yodon
    Dec 21, 2020
  3. John Thacher

    DMR Maintenance and Servicing Procedures Clarification 820.181

    John Thacher, Dec 17, 2020
    Replies:
    1
    Views:
    563
    yodon
    Dec 17, 2020
  4. siwing

    QC vs. QA on product release process

    siwing, Apr 4, 2020
    Replies:
    3
    Views:
    1,577
    yodon
    Apr 4, 2020
  5. talent.acquiring

    Design control requirements of Part 820

    talent.acquiring, Feb 5, 2019
    Replies:
    1
    Views:
    2,257
    yodon
    Feb 6, 2019
  6. Gözde Aktener

    Life time of product for a biodegradable device

    Gözde Aktener, Aug 31, 2018
    Replies:
    3
    Views:
    2,542
    Terry Spirk
    Oct 13, 2020
  7. subbash

    Clarification regarding tests in IEC 60601-2-25

    subbash, Aug 8, 2018
    Replies:
    0
    Views:
    933
    subbash
    Aug 8, 2018
  8. Shaun Me

    Exporting from the UK to Canada

    Shaun Me, Jun 1, 2018
    Replies:
    1
    Views:
    1,039
    yodon
    Jun 1, 2018
  9. Dave14867

    Excel or Access, which is better to use

    Dave14867, Apr 14, 2018
    Replies:
    5
    Views:
    1,441
    Dave14867
    Apr 18, 2018
  10. DeborahLong

    want to promote medical website

    DeborahLong, Dec 2, 2017
    Replies:
    0
    Views:
    873
    DeborahLong
    Dec 2, 2017
  11. MKenn

    Are Capability Studies a regulatory requirement ?

    MKenn, Mar 3, 2017
    Replies:
    10
    Views:
    2,290
    Vintage Goose
    Mar 9, 2017
  12. Emilia

    "Catch up" 510k

    Emilia, Sep 13, 2016
    Replies:
    3
    Views:
    2,471
    Al Weisenborn
    Feb 27, 2018
  13. Ronen E

    2015 Annual FDA Medical Device Quality System Data

    Ronen E, Mar 17, 2016
    Replies:
    2
    Views:
    1,764
    Ronen E
    Mar 17, 2016
  14. QAengineer13

    Regulatory Document Structure For NPI

    QAengineer13, Feb 23, 2016
    Replies:
    6
    Views:
    1,893
    QAengineer13
    Feb 25, 2016
  15. Daliane

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

    Daliane, Feb 8, 2016
    Replies:
    2
    Views:
    5,454
    Daliane
    Feb 12, 2016
  16. Vintage Goose

    De Novo Route

    Vintage Goose, Feb 2, 2016
    Replies:
    0
    Views:
    960
    Vintage Goose
    Feb 2, 2016
  17. QA Bee

    Real Time Stability

    QA Bee, Jan 14, 2016
    Replies:
    3
    Views:
    1,867
    Ronen E
    Jan 18, 2016
  18. Jo Campbell

    EtO Sterilisation Validation

    Jo Campbell, Jan 5, 2016
    Replies:
    1
    Views:
    1,168
    Ronen E
    Jan 5, 2016
  19. MarkMeer

    Justifying NOT following an FDA guidance?

    MarkMeer, Jan 5, 2016
    Replies:
    12
    Views:
    2,630
    MarkMeer
    Jan 9, 2016
  20. Abdullah

    Assembly and Packaging areas separation ??!!!

    Abdullah, Dec 22, 2015
    Replies:
    9
    Views:
    1,855
    Pads38
    Jan 4, 2016
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