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US Medical Device Regulations

United States Medical Device Regulations

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  1. QualityPerspective

    FDA 21 CFR 803 Device Malfunction

    QualityPerspective, Feb 1, 2024
    Replies:
    3
    Views:
    672
    yodon
    Feb 5, 2024
  2. JustDesign

    Dropping MDSAP?

    JustDesign, Mar 13, 2023
    Replies:
    1
    Views:
    1,508
    Jennifer Kirley
    Mar 13, 2023
  3. km533

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

    km533, Feb 17, 2023
    Replies:
    4
    Views:
    484
    km533
    Feb 21, 2023
  4. Chaïma

    Economic operators in the US

    Chaïma, Nov 24, 2020
    Replies:
    0
    Views:
    3,824
    Chaïma
    Nov 24, 2020
  5. MIGUEL LUNA

    Question about Section 8.3.4 Rework

    MIGUEL LUNA, Jan 6, 2020
    Replies:
    7
    Views:
    3,323
    Andy Nichols
    Jan 8, 2020
  6. Qualityforum Mainar

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

    Qualityforum Mainar, Feb 6, 2017
    Replies:
    2
    Views:
    1,254
    yodon
    Feb 24, 2017
  7. Amaka Okafor

    Getting FDA Pre-Market Approval

    Amaka Okafor, Sep 1, 2016
    Replies:
    1
    Views:
    943
    Vintage Goose
    Sep 1, 2016
  8. Terrance

    UDI Labeling Requirements

    Terrance, Jun 14, 2016
    Replies:
    5
    Views:
    1,672
    Vintage Goose
    Sep 1, 2016
  9. MarkMeer

    Mobile Medical Applications & Platform Validation

    MarkMeer, May 31, 2016
    Replies:
    4
    Views:
    2,246
    MarkMeer
    Jun 1, 2016
  10. Sing Wee

    Medical device shelf life

    Sing Wee, May 16, 2016
    Replies:
    2
    Views:
    1,208
    Zara Joyce
    May 9, 2017
  11. Pads38

    FDA consensus standards updated

    Pads38, Apr 6, 2016
    Replies:
    0
    Views:
    955
    Pads38
    Apr 6, 2016
  12. ARNEL MONTERO

    Minimum FDA Requirements for Distributors

    ARNEL MONTERO, Mar 23, 2016
    Replies:
    2
    Views:
    1,348
    Zara Joyce
    May 5, 2017
  13. 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
  14. Somashekar

    FDA inspection pre-announcement, specific situation

    Somashekar, Mar 12, 2016
    Replies:
    2
    Views:
    1,332
    Somashekar
    Mar 15, 2016
  15. 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
  16. Ronen E

    FDA releases safety communication on skull clamps

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

    Device Removals - FDA notification requirements

    OrangeIsEnergy, Feb 19, 2016
    Replies:
    2
    Views:
    1,089
    OrangeIsEnergy
    Feb 24, 2016
  18. Jo Campbell

    Full Sterilisation Validation for Novel Devices

    Jo Campbell, Feb 10, 2016
    Replies:
    2
    Views:
    1,254
    Jo Campbell
    Feb 12, 2016
  19. 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
  20. Ronen E

    CDRH releases 2016-2017 strategic priorities

    Ronen E, Jan 13, 2016
    Replies:
    0
    Views:
    1,003
    Ronen E
    Jan 13, 2016
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