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US Medical Device Regulations

United States Medical Device Regulations

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  1. Chaïma

    Economic operators in the US

    Chaïma, Nov 24, 2020
    Replies:
    0
    Views:
    3,822
    Chaïma
    Nov 24, 2020
  2. Pads38

    FDA consensus standards updated

    Pads38, Apr 6, 2016
    Replies:
    0
    Views:
    944
    Pads38
    Apr 6, 2016
  3. Ronen E

    FDA proposes to ban powdered surgeon's & examination gloves

    Ronen E, Mar 22, 2016
    Replies:
    0
    Views:
    999
    Ronen E
    Mar 22, 2016
  4. Ronen E

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

    Ronen E, Mar 4, 2016
    Replies:
    0
    Views:
    1,107
    Ronen E
    Mar 4, 2016
  5. Ronen E

    FDA releases safety communication on skull clamps

    Ronen E, Feb 25, 2016
    Replies:
    0
    Views:
    993
    Ronen E
    Feb 25, 2016
  6. Ronen E

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

    Ronen E, Feb 5, 2016
    Replies:
    0
    Views:
    978
    Ronen E
    Feb 5, 2016
  7. Ronen E

    CDRH releases 2016-2017 strategic priorities

    Ronen E, Jan 13, 2016
    Replies:
    0
    Views:
    999
    Ronen E
    Jan 13, 2016
  8. Debra V

    FDA updates list of recognized standards

    Debra V, Aug 18, 2015
    Replies:
    0
    Views:
    826
    Debra V
    Aug 18, 2015
  9. JustDesign

    Dropping MDSAP?

    JustDesign, Mar 13, 2023
    Replies:
    1
    Views:
    1,504
    Jennifer Kirley
    Mar 13, 2023
  10. nikolaos

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

    nikolaos, Aug 11, 2015
    Replies:
    1
    Views:
    1,414
    Zara Joyce
    May 5, 2017
  11. Amaka Okafor

    Getting FDA Pre-Market Approval

    Amaka Okafor, Sep 1, 2016
    Replies:
    1
    Views:
    940
    Vintage Goose
    Sep 1, 2016
  12. MarkMeer

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

    MarkMeer, Jan 13, 2016
    Replies:
    1
    Views:
    1,207
    DavidD
    Jan 13, 2016
  13. Sing Wee

    Medical device shelf life

    Sing Wee, May 16, 2016
    Replies:
    2
    Views:
    1,200
    Zara Joyce
    May 9, 2017
  14. ARNEL MONTERO

    Minimum FDA Requirements for Distributors

    ARNEL MONTERO, Mar 23, 2016
    Replies:
    2
    Views:
    1,340
    Zara Joyce
    May 5, 2017
  15. Qualityforum Mainar

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

    Qualityforum Mainar, Feb 6, 2017
    Replies:
    2
    Views:
    1,250
    yodon
    Feb 24, 2017
  16. Somashekar

    FDA inspection pre-announcement, specific situation

    Somashekar, Mar 12, 2016
    Replies:
    2
    Views:
    1,330
    Somashekar
    Mar 15, 2016
  17. OrangeIsEnergy

    Device Removals - FDA notification requirements

    OrangeIsEnergy, Feb 19, 2016
    Replies:
    2
    Views:
    1,084
    OrangeIsEnergy
    Feb 24, 2016
  18. Jo Campbell

    Full Sterilisation Validation for Novel Devices

    Jo Campbell, Feb 10, 2016
    Replies:
    2
    Views:
    1,250
    Jo Campbell
    Feb 12, 2016
  19. QualityPerspective

    FDA 21 CFR 803 Device Malfunction

    QualityPerspective, Feb 1, 2024
    Replies:
    3
    Views:
    569
    yodon
    Feb 5, 2024
  20. km533

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

    km533, Feb 17, 2023
    Replies:
    4
    Views:
    474
    km533
    Feb 21, 2023
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