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Medical Devices (21 CFR Part 820)

Medical Devices (21 CFR Part 820)

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  1. Thorsten Twellman

    How to handle optional software feature that is part of a medical device, but not sold in the USA

    Thorsten Twellman, Nov 25, 2024
    Replies:
    1
    Views:
    1,141
    yodon
    Nov 25, 2024
  2. Bashar Deeb

    Department of Health Florida

    Bashar Deeb, Jun 24, 2024
    Replies:
    0
    Views:
    994
    Bashar Deeb
    Jun 24, 2024
  3. Tiffany Detzel

    Supplier Audit Question

    Tiffany Detzel, Nov 8, 2022
    Replies:
    6
    Views:
    3,769
    andic
    Nov 9, 2022
  4. rohit16

    Anyone know where you can sell medical devices?

    rohit16, Dec 21, 2020
    Replies:
    1
    Views:
    3,678
    yodon
    Dec 21, 2020
  5. John Thacher

    DMR Maintenance and Servicing Procedures Clarification 820.181

    John Thacher, Dec 17, 2020
    Replies:
    1
    Views:
    885
    yodon
    Dec 17, 2020
  6. Gözde Aktener

    Life time of product for a biodegradable device

    Gözde Aktener, Aug 31, 2018
    Replies:
    3
    Views:
    2,829
    Terry Spirk
    Oct 13, 2020
  7. siwing

    QC vs. QA on product release process

    siwing, Apr 4, 2020
    Replies:
    3
    Views:
    2,370
    yodon
    Apr 4, 2020
  8. talent.acquiring

    Design control requirements of Part 820

    talent.acquiring, Feb 5, 2019
    Replies:
    1
    Views:
    2,548
    yodon
    Feb 6, 2019
  9. subbash

    Clarification regarding tests in IEC 60601-2-25

    subbash, Aug 8, 2018
    Replies:
    0
    Views:
    1,217
    subbash
    Aug 8, 2018
  10. Shaun Me

    Exporting from the UK to Canada

    Shaun Me, Jun 1, 2018
    Replies:
    1
    Views:
    1,343
    yodon
    Jun 1, 2018
  11. Dave14867

    Excel or Access, which is better to use

    Dave14867, Apr 14, 2018
    Replies:
    5
    Views:
    1,782
    Dave14867
    Apr 18, 2018
  12. Emilia

    "Catch up" 510k

    Emilia, Sep 13, 2016
    Replies:
    3
    Views:
    2,895
    Al Weisenborn
    Feb 27, 2018
  13. DeborahLong

    want to promote medical website

    DeborahLong, Dec 2, 2017
    Replies:
    0
    Views:
    1,237
    DeborahLong
    Dec 2, 2017
  14. MKenn

    Are Capability Studies a regulatory requirement ?

    MKenn, Mar 3, 2017
    Replies:
    10
    Views:
    2,830
    Vintage Goose
    Mar 9, 2017
  15. Ronen E

    2015 Annual FDA Medical Device Quality System Data

    Ronen E, Mar 17, 2016
    Replies:
    2
    Views:
    2,089
    Ronen E
    Mar 17, 2016
  16. QAengineer13

    Regulatory Document Structure For NPI

    QAengineer13, Feb 23, 2016
    Replies:
    6
    Views:
    2,281
    QAengineer13
    Feb 25, 2016
  17. Daliane

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

    Daliane, Feb 8, 2016
    Replies:
    2
    Views:
    6,077
    Daliane
    Feb 12, 2016
  18. Vintage Goose

    De Novo Route

    Vintage Goose, Feb 2, 2016
    Replies:
    0
    Views:
    1,169
    Vintage Goose
    Feb 2, 2016
  19. QA Bee

    Real Time Stability

    QA Bee, Jan 14, 2016
    Replies:
    3
    Views:
    2,205
    Ronen E
    Jan 18, 2016
  20. MarkMeer

    Justifying NOT following an FDA guidance?

    MarkMeer, Jan 5, 2016
    Replies:
    12
    Views:
    3,081
    MarkMeer
    Jan 9, 2016
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