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ISO 13485 and ISO 14969 – Medical Devices QMS

ISO 13485 and ISO 14969 – Medical Devices Quality Management System

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  1. Mike Bodine

    Understanding the difference between ISO 13485 and 21 CFR 820

    Mike Bodine, Jan 25, 2017
    Replies:
    5
    Views:
    2,606
    ValeriaGar
    Nov 3, 2020
  2. GregL

    ISO 13485: Suppliers to Medical Device company

    GregL, Dec 6, 2016
    Replies:
    8
    Views:
    3,237
    indicator
    Sep 7, 2017
  3. MonteS

    Must Medical Device Subcomponent Manufacturers Perform IQs and OQs on Existing Equipment?

    MonteS, Sep 27, 2016
    Replies:
    2
    Views:
    953
    Candi1024
    Oct 11, 2016
  4. fialor

    Country of Origin or "Made In" Tags

    fialor, Sep 14, 2016
    Replies:
    2
    Views:
    872
    RoxaneB
    Sep 14, 2016
  5. Jura1752

    ISO 13485 7.4.1 Purchasing Process

    Jura1752, Aug 7, 2016
    Replies:
    1
    Views:
    2,173
    yodon
    Aug 8, 2016
  6. Nikki

    What is missing from my list for 13485 certification?

    Nikki, May 27, 2016
    Replies:
    9
    Views:
    1,787
    Vintage Goose
    Nov 23, 2016
  7. PoojaN

    ISO 13485 vs CFR 820

    PoojaN, May 26, 2016
    Replies:
    4
    Views:
    1,314
    Marc Smith
    May 27, 2016
  8. DarisQ

    New chapter 4.2.3 Medical Device file

    DarisQ, May 9, 2016
    Replies:
    4
    Views:
    4,842
    TerryMc
    Jul 15, 2016
  9. Nikki

    Validation during Design & Development

    Nikki, Apr 28, 2016
    Replies:
    1
    Views:
    775
    Ronen E
    Apr 28, 2016
  10. K Muela

    Purchasing data review requirements

    K Muela, Apr 26, 2016
    Replies:
    4
    Views:
    1,371
    matkins151
    Apr 28, 2016
  11. Nikki

    Do we have to validate every piece of new equipment?

    Nikki, Apr 18, 2016
    Replies:
    3
    Views:
    2,065
    Karl76
    Apr 29, 2016
  12. Nikki

    How do I validate our ERP system?

    Nikki, Apr 12, 2016
    Replies:
    6
    Views:
    4,974
    AcTouch
    Aug 14, 2017
  13. karenlin

    Every change required communication?

    karenlin, Apr 8, 2016
    Replies:
    3
    Views:
    1,077
    Jose Ramon Salazar
    Jun 20, 2017
  14. dr1vn

    Intentional reprocessing of a single use device

    dr1vn, Mar 18, 2016
    Replies:
    5
    Views:
    1,033
    Ronen E
    Mar 29, 2016
  15. Rachel

    Shelf life vs Expiration date

    Rachel, Mar 17, 2016
    Replies:
    7
    Views:
    11,210
    Eric Twiname
    Mar 22, 2016
  16. QA Bee

    ISO 13485 vs. EN ISO 13485

    QA Bee, Mar 14, 2016
    Replies:
    4
    Views:
    20,522
    Pads38
    Mar 15, 2016
  17. Steve Kent

    Quality Agreement

    Steve Kent, Mar 2, 2016
    Replies:
    3
    Views:
    1,472
    Marcelo Antunes
    Mar 4, 2016
  18. MarkMeer

    Does requirement to validate QMS software rule-out cloud-based apps?

    MarkMeer, Feb 29, 2016
    Replies:
    16
    Views:
    4,641
    MarkMeer
    Mar 22, 2016
  19. Nash Jan

    ISO 10993-1: 2009 Annex A Biological Evaluation Tests

    Nash Jan, Feb 15, 2016
    Replies:
    3
    Views:
    2,731
    RW Soller
    Feb 14, 2017
  20. QA Bee

    ISO 13485 Pre-Assessment

    QA Bee, Feb 11, 2016
    Replies:
    4
    Views:
    1,265
    QA Bee
    Feb 11, 2016
Showing threads 61 to 80 of 104

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