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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. Lindy

    MDSAP Registrar

    Lindy, Jan 18, 2019 at 3:58 PM
    Replies:
    1
    Views:
    22
    yodon
    Jan 18, 2019 at 10:02 PM
  2. Neha_Mate

    What is the Medical Device Classification?

    Neha_Mate, Jan 14, 2019 at 9:00 AM
    Replies:
    1
    Views:
    43
    Operon_Strategist
    Jan 14, 2019 at 9:09 AM
  3. Nikki

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

    Nikki, Sep 25, 2018
    Replies:
    3
    Views:
    315
    Marcelo Antunes
    Dec 4, 2018
  4. Greig

    ISO13485 - The correct standard for pharmaceutical packaging?

    Greig, Jul 3, 2018
    Replies:
    7
    Views:
    519
    Greig
    Nov 28, 2018
  5. Renaz

    PFMEA in low volume medical device manufacturing

    Renaz, Oct 20, 2018
    Replies:
    2
    Views:
    218
    John C. Abnet
    Oct 22, 2018
  6. Karly Chester Etzel

    Design and Development Plan

    Karly Chester Etzel, Sep 25, 2018
    Replies:
    4
    Views:
    262
    Karly Chester Etzel
    Oct 9, 2018
  7. Jimbo11

    Preparation For Upcoming External Audit 13485

    Jimbo11, Sep 3, 2018
    Replies:
    3
    Views:
    229
    Andy Nichols
    Sep 4, 2018
  8. Diane Hunt

    Question on One Sentence in 7.1 of ISO 13485:2016

    Diane Hunt, Aug 28, 2018
    Replies:
    4
    Views:
    197
    Diane Hunt
    Aug 29, 2018
  9. Nikki

    GDP - Having to give a reason to use N/A?

    Nikki, Jun 18, 2018
    Replies:
    7
    Views:
    239
    John C. Abnet
    Jun 19, 2018
  10. Lindy

    Real Registrar?

    Lindy, Apr 16, 2018
    Replies:
    4
    Views:
    405
    Andy Nichols
    Apr 16, 2018
  11. Lindy

    On-site Supplier Audit Checklist

    Lindy, Jan 31, 2018
    Replies:
    7
    Views:
    614
    RoxaneB
    Apr 9, 2018
  12. Udirn1

    Spare parts

    Udirn1, Feb 7, 2018
    Replies:
    1
    Views:
    186
    Vintage Goose
    Feb 15, 2018
  13. MarkMeer

    What's the deal with MDSAP?

    MarkMeer, Dec 11, 2015
    Replies:
    11
    Views:
    1,451
    Lindy
    Jan 26, 2018
  14. Lindy

    Correcting Audit Findings

    Lindy, Jan 10, 2018 ... 2
    Replies:
    25
    Views:
    954
    BradM
    Jan 25, 2018
  15. James Elwood

    13485 and Signed Documents

    James Elwood, Apr 25, 2017
    Replies:
    4
    Views:
    650
    Quality Manager Liz
    Nov 24, 2017
  16. Mohsin Farooqui

    Scoping Validation for Incoming Inspection Tools/Equipment

    Mohsin Farooqui, Nov 16, 2017
    Replies:
    1
    Views:
    241
    Vintage Goose
    Nov 17, 2017
  17. Qualityforum Mainar

    Does 13485:2016 - 7.2.3 Customer Communication include marketing?

    Qualityforum Mainar, Nov 10, 2017
    Replies:
    1
    Views:
    351
    yodon
    Nov 15, 2017
  18. ankit

    Need this standard-Help

    ankit, Oct 11, 2017
    Replies:
    1
    Views:
    294
    Atul Khandekar
    Oct 11, 2017
  19. ChuckD

    Assigning Serial number at final QC check

    ChuckD, Sep 1, 2017
    Replies:
    2
    Views:
    370
    indicator
    Sep 7, 2017
  20. GregL

    ISO 13485: Suppliers to Medical Device company

    GregL, Dec 6, 2016
    Replies:
    8
    Views:
    1,006
    indicator
    Sep 7, 2017
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