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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. MarkMeer

    What's the deal with MDSAP?

    MarkMeer, Dec 11, 2015
    Replies:
    11
    Views:
    2,950
    Lindy
    Jan 26, 2018
  2. Neha_Mate

    What is the Medical Device Classification?

    Neha_Mate, Jan 14, 2019
    Replies:
    0
    Views:
    666
    Neha_Mate
    Jan 14, 2019
  3. Nikki

    What is missing from my list for 13485 certification?

    Nikki, May 27, 2016
    Replies:
    9
    Views:
    1,805
    Vintage Goose
    Nov 23, 2016
  4. Nikki

    What is "Deduction of Points"?

    Nikki, Oct 14, 2020
    Replies:
    0
    Views:
    453
    Nikki
    Oct 14, 2020
  5. ValeriaGar

    What do you think about Remote Audit during COVID 19?

    ValeriaGar, Dec 22, 2020
    Replies:
    6
    Views:
    1,336
    Jennifer Kirley
    Dec 31, 2020
  6. Nikki

    Validation during Design & Development

    Nikki, Apr 28, 2016
    Replies:
    1
    Views:
    783
    Ronen E
    Apr 28, 2016
  7. JCIC49

    Use of Sharepoint for controlling documents

    JCIC49, Nov 27, 2015
    Replies:
    6
    Views:
    2,026
    Claes Gefvenberg
    Dec 1, 2015
  8. Francesco.l

    USB-IF standard includes also ISO13485

    Francesco.l, Apr 30, 2021
    Replies:
    1
    Views:
    739
    Andy Nichols
    Apr 30, 2021
  9. Nikki

    Updating QM to 13485:2016 - We do not make medical devices

    Nikki, Sep 25, 2018
    Replies:
    4
    Views:
    1,371
    tony s
    Mar 22, 2019
  10. Mike Bodine

    Understanding the difference between ISO 13485 and 21 CFR 820

    Mike Bodine, Jan 25, 2017
    Replies:
    5
    Views:
    2,655
    ValeriaGar
    Nov 3, 2020
  11. Susan7

    Supply for Medical Device - ISO 13485

    Susan7, Mar 21, 2019
    Replies:
    3
    Views:
    837
    tony s
    Mar 22, 2019
  12. Stephen1985

    Sterilisation of Medical Devices

    Stephen1985, Aug 2, 2021
    Replies:
    1
    Views:
    677
    yodon
    Aug 2, 2021
  13. Udirn1

    Spare parts

    Udirn1, Feb 7, 2018
    Replies:
    1
    Views:
    668
    Vintage Goose
    Feb 15, 2018
  14. Nikki

    Should we keep ISO 9001:2015 when we go for 13485 certification?

    Nikki, Jan 18, 2016
    Replies:
    8
    Views:
    1,839
    Scott K
    Feb 9, 2016
  15. Crossi89

    Should NCMR or rejection be part of DHR?

    Crossi89, Apr 18, 2024
    Replies:
    0
    Views:
    115
    Crossi89
    Apr 18, 2024
  16. Rachel

    Shelf life vs Expiration date

    Rachel, Mar 17, 2016
    Replies:
    7
    Views:
    11,359
    Eric Twiname
    Mar 22, 2016
  17. Mohsin Farooqui

    Scoping Validation for Incoming Inspection Tools/Equipment

    Mohsin Farooqui, Nov 16, 2017
    Replies:
    1
    Views:
    1,248
    Vintage Goose
    Nov 17, 2017
  18. QA Bee

    Risk Management Process

    QA Bee, Jan 5, 2016
    Replies:
    4
    Views:
    908
    QA Bee
    Jan 6, 2016
  19. Kymberly

    Review of quality records

    Kymberly, May 2, 2020
    Replies:
    2
    Views:
    666
    Andy Nichols
    May 3, 2020
  20. pcmc47

    Removing Non Value Added Inspection

    pcmc47, Jan 29, 2016
    Replies:
    2
    Views:
    1,058
    Bev D
    Jan 29, 2016
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