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Medical Devices (21 CFR Part 820)

Medical Devices (21 CFR Part 820)

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  1. Sreenu

    US FDA User Fees for FY 2016

    Sreenu, Aug 4, 2015
    Replies:
    0
    Views:
    16,474
    Sreenu
    Aug 4, 2015
  2. dosumi

    820.40 document controls

    dosumi, Aug 7, 2015
    Replies:
    5
    Views:
    2,005
    Gert Sørensen
    Sep 8, 2015
  3. Lee G.

    Quality Plan (FDA) requirement

    Lee G., Aug 21, 2015
    Replies:
    7
    Views:
    2,570
    Marcelo Antunes
    Aug 27, 2015
  4. qu1nn

    Veterinary - Medical Device - Weigh Scale - GMP requirement?

    qu1nn, Sep 17, 2015
    Replies:
    2
    Views:
    1,120
    Ronen E
    Sep 19, 2015
  5. Daliane

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

    Daliane, Oct 30, 2015
    Replies:
    4
    Views:
    1,623
    Daliane
    Nov 9, 2015
  6. Nadine

    Combination Products

    Nadine, Nov 9, 2015
    Replies:
    0
    Views:
    837
    Nadine
    Nov 9, 2015
  7. 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
  8. QAengineer13

    Design Reviews

    QAengineer13, Dec 18, 2015
    Replies:
    10
    Views:
    2,014
    MCW8888
    Dec 24, 2015
  9. Abdullah

    Assembly and Packaging areas separation ??!!!

    Abdullah, Dec 22, 2015
    Replies:
    9
    Views:
    1,866
    Pads38
    Jan 4, 2016
  10. MarkMeer

    Justifying NOT following an FDA guidance?

    MarkMeer, Jan 5, 2016
    Replies:
    12
    Views:
    2,647
    MarkMeer
    Jan 9, 2016
  11. Jo Campbell

    EtO Sterilisation Validation

    Jo Campbell, Jan 5, 2016
    Replies:
    1
    Views:
    1,170
    Ronen E
    Jan 5, 2016
  12. QA Bee

    Real Time Stability

    QA Bee, Jan 14, 2016
    Replies:
    3
    Views:
    1,872
    Ronen E
    Jan 18, 2016
  13. Vintage Goose

    De Novo Route

    Vintage Goose, Feb 2, 2016
    Replies:
    0
    Views:
    962
    Vintage Goose
    Feb 2, 2016
  14. Daliane

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

    Daliane, Feb 8, 2016
    Replies:
    2
    Views:
    5,466
    Daliane
    Feb 12, 2016
  15. QAengineer13

    Regulatory Document Structure For NPI

    QAengineer13, Feb 23, 2016
    Replies:
    6
    Views:
    1,907
    QAengineer13
    Feb 25, 2016
  16. 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
  17. Emilia

    "Catch up" 510k

    Emilia, Sep 13, 2016
    Replies:
    3
    Views:
    2,478
    Al Weisenborn
    Feb 27, 2018
  18. MKenn

    Are Capability Studies a regulatory requirement ?

    MKenn, Mar 3, 2017
    Replies:
    10
    Views:
    2,305
    Vintage Goose
    Mar 9, 2017
  19. DeborahLong

    want to promote medical website

    DeborahLong, Dec 2, 2017
    Replies:
    0
    Views:
    877
    DeborahLong
    Dec 2, 2017
  20. Dave14867

    Excel or Access, which is better to use

    Dave14867, Apr 14, 2018
    Replies:
    5
    Views:
    1,446
    Dave14867
    Apr 18, 2018
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