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US Medical Device Regulations

United States Medical Device Regulations

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  1. Sing Wee

    Medical device shelf life

    Sing Wee, May 16, 2016
    Replies:
    2
    Views:
    1,198
    Zara Joyce
    May 9, 2017
  2. Nikki

    Would the FDA audit my company?

    Nikki, Aug 12, 2015
    Replies:
    6
    Views:
    3,996
    Zara Joyce
    May 9, 2017
  3. MIGUEL LUNA

    Question about Section 8.3.4 Rework

    MIGUEL LUNA, Jan 6, 2020
    Replies:
    7
    Views:
    3,265
    Andy Nichols
    Jan 8, 2020
  4. Chaïma

    Economic operators in the US

    Chaïma, Nov 24, 2020
    Replies:
    0
    Views:
    3,820
    Chaïma
    Nov 24, 2020
  5. km533

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

    km533, Feb 17, 2023
    Replies:
    4
    Views:
    471
    km533
    Feb 21, 2023
  6. JustDesign

    Dropping MDSAP?

    JustDesign, Mar 13, 2023
    Replies:
    1
    Views:
    1,502
    Jennifer Kirley
    Mar 13, 2023
  7. QualityPerspective

    FDA 21 CFR 803 Device Malfunction

    QualityPerspective, Feb 1, 2024
    Replies:
    3
    Views:
    538
    yodon
    Feb 5, 2024
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