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Medical Devices (21 CFR Part 820)

Medical Devices (21 CFR Part 820)

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  1. DeborahLong

    want to promote medical website

    DeborahLong, Dec 2, 2017
    Replies:
    0
    Views:
    881
    DeborahLong
    Dec 2, 2017
  2. qu1nn

    Veterinary - Medical Device - Weigh Scale - GMP requirement?

    qu1nn, Sep 17, 2015
    Replies:
    2
    Views:
    1,122
    Ronen E
    Sep 19, 2015
  3. Sreenu

    US FDA User Fees for FY 2016

    Sreenu, Aug 4, 2015
    Replies:
    0
    Views:
    16,522
    Sreenu
    Aug 4, 2015
  4. Tiffany Detzel

    Supplier Audit Question

    Tiffany Detzel, Nov 8, 2022
    Replies:
    6
    Views:
    2,907
    andic
    Nov 9, 2022
  5. QAengineer13

    Regulatory Document Structure For NPI

    QAengineer13, Feb 23, 2016
    Replies:
    6
    Views:
    1,915
    QAengineer13
    Feb 25, 2016
  6. QA Bee

    Real Time Stability

    QA Bee, Jan 14, 2016
    Replies:
    3
    Views:
    1,878
    Ronen E
    Jan 18, 2016
  7. Lee G.

    Quality Plan (FDA) requirement

    Lee G., Aug 21, 2015
    Replies:
    7
    Views:
    2,584
    Marcelo Antunes
    Aug 27, 2015
  8. siwing

    QC vs. QA on product release process

    siwing, Apr 4, 2020
    Replies:
    3
    Views:
    1,607
    yodon
    Apr 4, 2020
  9. Gözde Aktener

    Life time of product for a biodegradable device

    Gözde Aktener, Aug 31, 2018
    Replies:
    3
    Views:
    2,553
    Terry Spirk
    Oct 13, 2020
  10. MarkMeer

    Justifying NOT following an FDA guidance?

    MarkMeer, Jan 5, 2016
    Replies:
    12
    Views:
    2,652
    MarkMeer
    Jan 9, 2016
  11. Daliane

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

    Daliane, Feb 8, 2016
    Replies:
    2
    Views:
    5,476
    Daliane
    Feb 12, 2016
  12. Shaun Me

    Exporting from the UK to Canada

    Shaun Me, Jun 1, 2018
    Replies:
    1
    Views:
    1,048
    yodon
    Jun 1, 2018
  13. Dave14867

    Excel or Access, which is better to use

    Dave14867, Apr 14, 2018
    Replies:
    5
    Views:
    1,448
    Dave14867
    Apr 18, 2018
  14. Jo Campbell

    EtO Sterilisation Validation

    Jo Campbell, Jan 5, 2016
    Replies:
    1
    Views:
    1,173
    Ronen E
    Jan 5, 2016
  15. John Thacher

    DMR Maintenance and Servicing Procedures Clarification 820.181

    John Thacher, Dec 17, 2020
    Replies:
    1
    Views:
    582
    yodon
    Dec 17, 2020
  16. QAengineer13

    Design Reviews

    QAengineer13, Dec 18, 2015
    Replies:
    10
    Views:
    2,018
    MCW8888
    Dec 24, 2015
  17. talent.acquiring

    Design control requirements of Part 820

    talent.acquiring, Feb 5, 2019
    Replies:
    1
    Views:
    2,270
    yodon
    Feb 6, 2019
  18. Vintage Goose

    De Novo Route

    Vintage Goose, Feb 2, 2016
    Replies:
    0
    Views:
    963
    Vintage Goose
    Feb 2, 2016
  19. Daliane

    CTD only for pharmaceutical products or also for IVD required?

    Daliane, Nov 11, 2015
    Replies:
    2
    Views:
    1,073
    Vintage Goose
    Nov 12, 2015
  20. Daliane

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

    Daliane, Oct 30, 2015
    Replies:
    4
    Views:
    1,629
    Daliane
    Nov 9, 2015
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