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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

    3rd Party Supplier Audit in China: ISO 13485 & 21 CFR 820

    Lindy, Apr 17, 2019
    Replies:
    3
    Views:
    441
    Andy Nichols
    Apr 26, 2019
  2. Nikki

    13485:2016 Internal Auditing Online Course?

    Nikki, Mar 8, 2019
    Replies:
    7
    Views:
    238
    Chaitany Thaker
    Apr 15, 2019
  3. Susan7

    Supply for Medical Device - ISO 13485

    Susan7, Mar 21, 2019
    Replies:
    3
    Views:
    215
    tony s
    Mar 22, 2019
  4. Nikki

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

    Nikki, Sep 25, 2018
    Replies:
    5
    Views:
    594
    tony s
    Mar 22, 2019
  5. Lindy

    Procedure Deviations

    Lindy, Feb 1, 2019
    Replies:
    3
    Views:
    125
    Andy Nichols
    Feb 1, 2019
  6. Lindy

    MDSAP Registrar

    Lindy, Jan 18, 2019
    Replies:
    3
    Views:
    180
    Andy Nichols
    Jan 21, 2019
  7. Neha_Mate

    What is the Medical Device Classification?

    Neha_Mate, Jan 14, 2019
    Replies:
    1
    Views:
    122
    Operon_Strategist
    Jan 14, 2019
  8. Greig

    ISO13485 - The correct standard for pharmaceutical packaging?

    Greig, Jul 3, 2018
    Replies:
    7
    Views:
    619
    Greig
    Nov 28, 2018
  9. Renaz

    PFMEA in low volume medical device manufacturing

    Renaz, Oct 20, 2018
    Replies:
    2
    Views:
    274
    John C. Abnet
    Oct 22, 2018
  10. Karly Chester Etzel

    Design and Development Plan

    Karly Chester Etzel, Sep 25, 2018
    Replies:
    4
    Views:
    398
    Karly Chester Etzel
    Oct 9, 2018
  11. Jimbo11

    Preparation For Upcoming External Audit 13485

    Jimbo11, Sep 3, 2018
    Replies:
    3
    Views:
    329
    Andy Nichols
    Sep 4, 2018
  12. Diane Hunt

    Question on One Sentence in 7.1 of ISO 13485:2016

    Diane Hunt, Aug 28, 2018
    Replies:
    4
    Views:
    306
    Diane Hunt
    Aug 29, 2018
  13. Nikki

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

    Nikki, Jun 18, 2018
    Replies:
    7
    Views:
    349
    John C. Abnet
    Jun 19, 2018
  14. Lindy

    Real Registrar?

    Lindy, Apr 16, 2018
    Replies:
    4
    Views:
    473
    Andy Nichols
    Apr 16, 2018
  15. Lindy

    On-site Supplier Audit Checklist

    Lindy, Jan 31, 2018
    Replies:
    7
    Views:
    954
    RoxaneB
    Apr 9, 2018
  16. Udirn1

    Spare parts

    Udirn1, Feb 7, 2018
    Replies:
    1
    Views:
    233
    Vintage Goose
    Feb 15, 2018
  17. MarkMeer

    What's the deal with MDSAP?

    MarkMeer, Dec 11, 2015
    Replies:
    11
    Views:
    1,657
    Lindy
    Jan 26, 2018
  18. Lindy

    Correcting Audit Findings

    Lindy, Jan 10, 2018 ... 2
    Replies:
    25
    Views:
    1,128
    BradM
    Jan 25, 2018
  19. James Elwood

    13485 and Signed Documents

    James Elwood, Apr 25, 2017
    Replies:
    4
    Views:
    713
    Quality Manager Liz
    Nov 24, 2017
  20. Mohsin Farooqui

    Scoping Validation for Incoming Inspection Tools/Equipment

    Mohsin Farooqui, Nov 16, 2017
    Replies:
    1
    Views:
    346
    Vintage Goose
    Nov 17, 2017
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