1. This site uses cookies. By continuing to use this site, you are agreeing to our use of cookies. Learn More.
Dismiss Notice
You must be a registered member in order to post messages and view/download attached files in this forum.
Click here to register.

US Medical Device Regulations

United States Medical Device Regulations

Page 1 of 2
Sort By:
Title Start Date
Replies Views ↑
Last Message
  1. 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
  2. QualityPerspective

    FDA 21 CFR 803 Device Malfunction

    QualityPerspective, Feb 1, 2024
    Replies:
    3
    Views:
    577
    yodon
    Feb 5, 2024
  3. Debra V

    FDA updates list of recognized standards

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

    Getting FDA Pre-Market Approval

    Amaka Okafor, Sep 1, 2016
    Replies:
    1
    Views:
    940
    Vintage Goose
    Sep 1, 2016
  5. Pads38

    FDA consensus standards updated

    Pads38, Apr 6, 2016
    Replies:
    0
    Views:
    945
    Pads38
    Apr 6, 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

    FDA releases safety communication on skull clamps

    Ronen E, Feb 25, 2016
    Replies:
    0
    Views:
    993
    Ronen E
    Feb 25, 2016
  8. 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
  9. Ronen E

    CDRH releases 2016-2017 strategic priorities

    Ronen E, Jan 13, 2016
    Replies:
    0
    Views:
    999
    Ronen E
    Jan 13, 2016
  10. OrangeIsEnergy

    Device Removals - FDA notification requirements

    OrangeIsEnergy, Feb 19, 2016
    Replies:
    2
    Views:
    1,085
    OrangeIsEnergy
    Feb 24, 2016
  11. 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
  12. Sing Wee

    Medical device shelf life

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

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

    MarkMeer, Jan 13, 2016
    Replies:
    1
    Views:
    1,208
    DavidD
    Jan 13, 2016
  14. 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
  15. Jo Campbell

    Full Sterilisation Validation for Novel Devices

    Jo Campbell, Feb 10, 2016
    Replies:
    2
    Views:
    1,251
    Jo Campbell
    Feb 12, 2016
  16. Candi1024

    Engineers Specs Vs. Functional Specs.

    Candi1024, Oct 2, 2015
    Replies:
    5
    Views:
    1,256
    Andy Nichols
    Oct 9, 2015
  17. Somashekar

    FDA inspection pre-announcement, specific situation

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

    Minimum FDA Requirements for Distributors

    ARNEL MONTERO, Mar 23, 2016
    Replies:
    2
    Views:
    1,342
    Zara Joyce
    May 5, 2017
  19. 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
  20. JustDesign

    Dropping MDSAP?

    JustDesign, Mar 13, 2023
    Replies:
    1
    Views:
    1,504
    Jennifer Kirley
    Mar 13, 2023
Showing threads 1 to 20 of 27

Thread Display Options

Loading...
Page 1 of 2