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US Medical Device Regulations

United States Medical Device Regulations

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  1. Vintage Goose

    FDA UDI & GUDID

    Vintage Goose, Oct 13, 2015
    Replies:
    8
    Views:
    2,402
    Jim Hagenbaugh
    Jan 8, 2016
  2. MIGUEL LUNA

    Question about Section 8.3.4 Rework

    MIGUEL LUNA, Jan 6, 2020
    Replies:
    7
    Views:
    3,325
    Andy Nichols
    Jan 8, 2020
  3. QAengineer13

    Software Validation: Is 21 CFR §820.70(i) applicable to Minitab, Moldflow etc?

    QAengineer13, Aug 24, 2015
    Replies:
    7
    Views:
    4,533
    BradM
    Sep 22, 2015
  4. Nikki

    Would the FDA audit my company?

    Nikki, Aug 12, 2015
    Replies:
    6
    Views:
    4,007
    Zara Joyce
    May 9, 2017
  5. Terrance

    UDI Labeling Requirements

    Terrance, Jun 14, 2016
    Replies:
    5
    Views:
    1,673
    Vintage Goose
    Sep 1, 2016
  6. Candi1024

    Engineers Specs Vs. Functional Specs.

    Candi1024, Oct 2, 2015
    Replies:
    5
    Views:
    1,261
    Andy Nichols
    Oct 9, 2015
  7. 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
  8. MarkMeer

    Mobile Medical Applications & Platform Validation

    MarkMeer, May 31, 2016
    Replies:
    4
    Views:
    2,246
    MarkMeer
    Jun 1, 2016
  9. QualityPerspective

    FDA 21 CFR 803 Device Malfunction

    QualityPerspective, Feb 1, 2024
    Replies:
    3
    Views:
    676
    yodon
    Feb 5, 2024
  10. Sing Wee

    Medical device shelf life

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

    Minimum FDA Requirements for Distributors

    ARNEL MONTERO, Mar 23, 2016
    Replies:
    2
    Views:
    1,348
    Zara Joyce
    May 5, 2017
  12. Qualityforum Mainar

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

    Qualityforum Mainar, Feb 6, 2017
    Replies:
    2
    Views:
    1,255
    yodon
    Feb 24, 2017
  13. Somashekar

    FDA inspection pre-announcement, specific situation

    Somashekar, Mar 12, 2016
    Replies:
    2
    Views:
    1,332
    Somashekar
    Mar 15, 2016
  14. OrangeIsEnergy

    Device Removals - FDA notification requirements

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

    Full Sterilisation Validation for Novel Devices

    Jo Campbell, Feb 10, 2016
    Replies:
    2
    Views:
    1,254
    Jo Campbell
    Feb 12, 2016
  16. JustDesign

    Dropping MDSAP?

    JustDesign, Mar 13, 2023
    Replies:
    1
    Views:
    1,508
    Jennifer Kirley
    Mar 13, 2023
  17. nikolaos

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

    nikolaos, Aug 11, 2015
    Replies:
    1
    Views:
    1,418
    Zara Joyce
    May 5, 2017
  18. Amaka Okafor

    Getting FDA Pre-Market Approval

    Amaka Okafor, Sep 1, 2016
    Replies:
    1
    Views:
    943
    Vintage Goose
    Sep 1, 2016
  19. MarkMeer

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

    MarkMeer, Jan 13, 2016
    Replies:
    1
    Views:
    1,211
    DavidD
    Jan 13, 2016
  20. Chaïma

    Economic operators in the US

    Chaïma, Nov 24, 2020
    Replies:
    0
    Views:
    3,826
    Chaïma
    Nov 24, 2020
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