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. QualityPerspective

    FDA 21 CFR 803 Device Malfunction

    QualityPerspective, Feb 1, 2024
    Replies:
    3
    Views:
    1,049
    yodon
    Feb 5, 2024
  2. JustDesign

    Dropping MDSAP?

    JustDesign, Mar 13, 2023
    Replies:
    1
    Views:
    1,532
    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:
    510
    km533
    Feb 21, 2023
  4. Chaïma

    Economic operators in the US

    Chaïma, Nov 24, 2020
    Replies:
    0
    Views:
    3,844
    Chaïma
    Nov 24, 2020
  5. MIGUEL LUNA

    Question about Section 8.3.4 Rework

    MIGUEL LUNA, Jan 6, 2020
    Replies:
    7
    Views:
    3,431
    Andy Nichols
    Jan 8, 2020
  6. Nikki

    Would the FDA audit my company?

    Nikki, Aug 12, 2015
    Replies:
    6
    Views:
    4,022
    Zara Joyce
    May 9, 2017
  7. Sing Wee

    Medical device shelf life

    Sing Wee, May 16, 2016
    Replies:
    2
    Views:
    1,238
    Zara Joyce
    May 9, 2017
  8. nikolaos

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

    nikolaos, Aug 11, 2015
    Replies:
    1
    Views:
    1,438
    Zara Joyce
    May 5, 2017
  9. ARNEL MONTERO

    Minimum FDA Requirements for Distributors

    ARNEL MONTERO, Mar 23, 2016
    Replies:
    2
    Views:
    1,371
    Zara Joyce
    May 5, 2017
  10. Qualityforum Mainar

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

    Qualityforum Mainar, Feb 6, 2017
    Replies:
    2
    Views:
    1,278
    yodon
    Feb 24, 2017
  11. Terrance

    UDI Labeling Requirements

    Terrance, Jun 14, 2016
    Replies:
    5
    Views:
    1,706
    Vintage Goose
    Sep 1, 2016
  12. Amaka Okafor

    Getting FDA Pre-Market Approval

    Amaka Okafor, Sep 1, 2016
    Replies:
    1
    Views:
    965
    Vintage Goose
    Sep 1, 2016
  13. MarkMeer

    Mobile Medical Applications & Platform Validation

    MarkMeer, May 31, 2016
    Replies:
    4
    Views:
    2,348
    MarkMeer
    Jun 1, 2016
  14. Pads38

    FDA consensus standards updated

    Pads38, Apr 6, 2016
    Replies:
    0
    Views:
    985
    Pads38
    Apr 6, 2016
  15. Ronen E

    FDA proposes to ban powdered surgeon's & examination gloves

    Ronen E, Mar 22, 2016
    Replies:
    0
    Views:
    1,033
    Ronen E
    Mar 22, 2016
  16. Somashekar

    FDA inspection pre-announcement, specific situation

    Somashekar, Mar 12, 2016
    Replies:
    2
    Views:
    1,353
    Somashekar
    Mar 15, 2016
  17. Ronen E

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

    Ronen E, Mar 4, 2016
    Replies:
    0
    Views:
    1,138
    Ronen E
    Mar 4, 2016
  18. Ronen E

    FDA releases safety communication on skull clamps

    Ronen E, Feb 25, 2016
    Replies:
    0
    Views:
    1,031
    Ronen E
    Feb 25, 2016
  19. OrangeIsEnergy

    Device Removals - FDA notification requirements

    OrangeIsEnergy, Feb 19, 2016
    Replies:
    2
    Views:
    1,114
    OrangeIsEnergy
    Feb 24, 2016
  20. Jo Campbell

    Full Sterilisation Validation for Novel Devices

    Jo Campbell, Feb 10, 2016
    Replies:
    2
    Views:
    1,275
    Jo Campbell
    Feb 12, 2016
Showing threads 1 to 20 of 27

Thread Display Options

Loading...
Page 1 of 2