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US Medical Device Regulations

United States Medical Device Regulations

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  1. QAengineer13

    Software Validation: Is 21 CFR §820.70(i) applicable to Minitab, Moldflow etc?

    QAengineer13, Aug 24, 2015
    Replies:
    7
    Views:
    4,505
    BradM
    Sep 22, 2015
  2. Nikki

    Would the FDA audit my company?

    Nikki, Aug 12, 2015
    Replies:
    6
    Views:
    3,993
    Zara Joyce
    May 9, 2017
  3. Chaïma

    Economic operators in the US

    Chaïma, Nov 24, 2020
    Replies:
    0
    Views:
    3,818
    Chaïma
    Nov 24, 2020
  4. MIGUEL LUNA

    Question about Section 8.3.4 Rework

    MIGUEL LUNA, Jan 6, 2020
    Replies:
    7
    Views:
    3,250
    Andy Nichols
    Jan 8, 2020
  5. Vintage Goose

    FDA UDI & GUDID

    Vintage Goose, Oct 13, 2015
    Replies:
    8
    Views:
    2,367
    Jim Hagenbaugh
    Jan 8, 2016
  6. MarkMeer

    Mobile Medical Applications & Platform Validation

    MarkMeer, May 31, 2016
    Replies:
    4
    Views:
    2,200
    MarkMeer
    Jun 1, 2016
  7. Terrance

    UDI Labeling Requirements

    Terrance, Jun 14, 2016
    Replies:
    5
    Views:
    1,655
    Vintage Goose
    Sep 1, 2016
  8. JustDesign

    Dropping MDSAP?

    JustDesign, Mar 13, 2023
    Replies:
    1
    Views:
    1,498
    Jennifer Kirley
    Mar 13, 2023
  9. nikolaos

    US FDA exempts low-risk, some Class II devices from 510(K) requirements

    nikolaos, Aug 11, 2015
    Replies:
    1
    Views:
    1,410
    Zara Joyce
    May 5, 2017
  10. ARNEL MONTERO

    Minimum FDA Requirements for Distributors

    ARNEL MONTERO, Mar 23, 2016
    Replies:
    2
    Views:
    1,332
    Zara Joyce
    May 5, 2017
  11. Somashekar

    FDA inspection pre-announcement, specific situation

    Somashekar, Mar 12, 2016
    Replies:
    2
    Views:
    1,325
    Somashekar
    Mar 15, 2016
  12. Candi1024

    Engineers Specs Vs. Functional Specs.

    Candi1024, Oct 2, 2015
    Replies:
    5
    Views:
    1,252
    Andy Nichols
    Oct 9, 2015
  13. Qualityforum Mainar

    Definition of Point of Use for Corrections and Removals - 21CFR806

    Qualityforum Mainar, Feb 6, 2017
    Replies:
    2
    Views:
    1,246
    yodon
    Feb 24, 2017
  14. Jo Campbell

    Full Sterilisation Validation for Novel Devices

    Jo Campbell, Feb 10, 2016
    Replies:
    2
    Views:
    1,245
    Jo Campbell
    Feb 12, 2016
  15. MarkMeer

    Pressure units for US labeling (atm, psi, or in-Hg)

    MarkMeer, Jan 13, 2016
    Replies:
    1
    Views:
    1,206
    DavidD
    Jan 13, 2016
  16. Sing Wee

    Medical device shelf life

    Sing Wee, May 16, 2016
    Replies:
    2
    Views:
    1,195
    Zara Joyce
    May 9, 2017
  17. Ronen E

    FDA addresses devices service, maintenance, refurbishment and alteration by OEM and 3rd parties

    Ronen E, Mar 4, 2016
    Replies:
    0
    Views:
    1,104
    Ronen E
    Mar 4, 2016
  18. OrangeIsEnergy

    Device Removals - FDA notification requirements

    OrangeIsEnergy, Feb 19, 2016
    Replies:
    2
    Views:
    1,080
    OrangeIsEnergy
    Feb 24, 2016
  19. Ronen E

    FDA proposes to ban powdered surgeon's & examination gloves

    Ronen E, Mar 22, 2016
    Replies:
    0
    Views:
    997
    Ronen E
    Mar 22, 2016
  20. Ronen E

    CDRH releases 2016-2017 strategic priorities

    Ronen E, Jan 13, 2016
    Replies:
    0
    Views:
    997
    Ronen E
    Jan 13, 2016
Showing threads 1 to 20 of 27

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