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US Medical Device Regulations

United States Medical Device Regulations

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  1. Nikki

    Would the FDA audit my company?

    Nikki, Aug 12, 2015
    Replies:
    6
    Views:
    4,006
    Zara Joyce
    May 9, 2017
  2. nikolaos

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

    nikolaos, Aug 11, 2015
    Replies:
    1
    Views:
    1,418
    Zara Joyce
    May 5, 2017
  3. Terrance

    UDI Labeling Requirements

    Terrance, Jun 14, 2016
    Replies:
    5
    Views:
    1,672
    Vintage Goose
    Sep 1, 2016
  4. QAengineer13

    Software Validation: Is 21 CFR ยง820.70(i) applicable to Minitab, Moldflow etc?

    QAengineer13, Aug 24, 2015
    Replies:
    7
    Views:
    4,533
    BradM
    Sep 22, 2015
  5. MIGUEL LUNA

    Question about Section 8.3.4 Rework

    MIGUEL LUNA, Jan 6, 2020
    Replies:
    7
    Views:
    3,320
    Andy Nichols
    Jan 8, 2020
  6. MarkMeer

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

    MarkMeer, Jan 13, 2016
    Replies:
    1
    Views:
    1,211
    DavidD
    Jan 13, 2016
  7. km533

    Part 11 Guidance /risk of including unqualified system/ids in a change request

    km533, Feb 17, 2023
    Replies:
    4
    Views:
    483
    km533
    Feb 21, 2023
  8. MarkMeer

    Mobile Medical Applications & Platform Validation

    MarkMeer, May 31, 2016
    Replies:
    4
    Views:
    2,246
    MarkMeer
    Jun 1, 2016
  9. ARNEL MONTERO

    Minimum FDA Requirements for Distributors

    ARNEL MONTERO, Mar 23, 2016
    Replies:
    2
    Views:
    1,348
    Zara Joyce
    May 5, 2017
  10. Sing Wee

    Medical device shelf life

    Sing Wee, May 16, 2016
    Replies:
    2
    Views:
    1,208
    Zara Joyce
    May 9, 2017
  11. Amaka Okafor

    Getting FDA Pre-Market Approval

    Amaka Okafor, Sep 1, 2016
    Replies:
    1
    Views:
    943
    Vintage Goose
    Sep 1, 2016
  12. Jo Campbell

    Full Sterilisation Validation for Novel Devices

    Jo Campbell, Feb 10, 2016
    Replies:
    2
    Views:
    1,254
    Jo Campbell
    Feb 12, 2016
  13. Debra V

    FDA updates list of recognized standards

    Debra V, Aug 18, 2015
    Replies:
    0
    Views:
    829
    Debra V
    Aug 18, 2015
  14. Vintage Goose

    FDA UDI & GUDID

    Vintage Goose, Oct 13, 2015
    Replies:
    8
    Views:
    2,402
    Jim Hagenbaugh
    Jan 8, 2016
  15. Ronen E

    FDA releases safety communication on skull clamps

    Ronen E, Feb 25, 2016
    Replies:
    0
    Views:
    995
    Ronen E
    Feb 25, 2016
  16. Ronen E

    FDA releases final guidance on Applying Human Factors and Usability Engineering to Medical Devices

    Ronen E, Feb 5, 2016
    Replies:
    0
    Views:
    982
    Ronen E
    Feb 5, 2016
  17. Ronen E

    FDA proposes to ban powdered surgeon's & examination gloves

    Ronen E, Mar 22, 2016
    Replies:
    0
    Views:
    1,004
    Ronen E
    Mar 22, 2016
  18. Somashekar

    FDA inspection pre-announcement, specific situation

    Somashekar, Mar 12, 2016
    Replies:
    2
    Views:
    1,332
    Somashekar
    Mar 15, 2016
  19. Pads38

    FDA consensus standards updated

    Pads38, Apr 6, 2016
    Replies:
    0
    Views:
    955
    Pads38
    Apr 6, 2016
  20. Ronen E

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

    Ronen E, Mar 4, 2016
    Replies:
    0
    Views:
    1,109
    Ronen E
    Mar 4, 2016
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