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US Medical Device Regulations

United States Medical Device Regulations

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  1. 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
  2. Nikki

    Would the FDA audit my company?

    Nikki, Aug 12, 2015
    Replies:
    6
    Views:
    4,001
    Zara Joyce
    May 9, 2017
  3. Debra V

    FDA updates list of recognized standards

    Debra V, Aug 18, 2015
    Replies:
    0
    Views:
    826
    Debra V
    Aug 18, 2015
  4. QAengineer13

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

    QAengineer13, Aug 24, 2015
    Replies:
    7
    Views:
    4,523
    BradM
    Sep 22, 2015
  5. Candi1024

    Engineers Specs Vs. Functional Specs.

    Candi1024, Oct 2, 2015
    Replies:
    5
    Views:
    1,256
    Andy Nichols
    Oct 9, 2015
  6. Vintage Goose

    FDA UDI & GUDID

    Vintage Goose, Oct 13, 2015
    Replies:
    8
    Views:
    2,382
    Jim Hagenbaugh
    Jan 8, 2016
  7. MarkMeer

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

    MarkMeer, Jan 13, 2016
    Replies:
    1
    Views:
    1,208
    DavidD
    Jan 13, 2016
  8. Ronen E

    CDRH releases 2016-2017 strategic priorities

    Ronen E, Jan 13, 2016
    Replies:
    0
    Views:
    999
    Ronen E
    Jan 13, 2016
  9. 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
  10. Jo Campbell

    Full Sterilisation Validation for Novel Devices

    Jo Campbell, Feb 10, 2016
    Replies:
    2
    Views:
    1,251
    Jo Campbell
    Feb 12, 2016
  11. OrangeIsEnergy

    Device Removals - FDA notification requirements

    OrangeIsEnergy, Feb 19, 2016
    Replies:
    2
    Views:
    1,085
    OrangeIsEnergy
    Feb 24, 2016
  12. Ronen E

    FDA releases safety communication on skull clamps

    Ronen E, Feb 25, 2016
    Replies:
    0
    Views:
    993
    Ronen E
    Feb 25, 2016
  13. 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
  14. Somashekar

    FDA inspection pre-announcement, specific situation

    Somashekar, Mar 12, 2016
    Replies:
    2
    Views:
    1,330
    Somashekar
    Mar 15, 2016
  15. 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
  16. ARNEL MONTERO

    Minimum FDA Requirements for Distributors

    ARNEL MONTERO, Mar 23, 2016
    Replies:
    2
    Views:
    1,342
    Zara Joyce
    May 5, 2017
  17. Pads38

    FDA consensus standards updated

    Pads38, Apr 6, 2016
    Replies:
    0
    Views:
    945
    Pads38
    Apr 6, 2016
  18. Sing Wee

    Medical device shelf life

    Sing Wee, May 16, 2016
    Replies:
    2
    Views:
    1,201
    Zara Joyce
    May 9, 2017
  19. MarkMeer

    Mobile Medical Applications & Platform Validation

    MarkMeer, May 31, 2016
    Replies:
    4
    Views:
    2,225
    MarkMeer
    Jun 1, 2016
  20. Terrance

    UDI Labeling Requirements

    Terrance, Jun 14, 2016
    Replies:
    5
    Views:
    1,663
    Vintage Goose
    Sep 1, 2016
Showing threads 1 to 20 of 27

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