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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. laden

    Record Management (paper-based document system)

    laden, Apr 21, 2020
    Replies:
    9
    Views:
    1,013
    Mike S.
    Apr 29, 2020
  2. Lindy

    Real Registrar?

    Lindy, Apr 16, 2018
    Replies:
    4
    Views:
    1,025
    Andy Nichols
    Apr 16, 2018
  3. Diane Hunt

    Question on One Sentence in 7.1 of ISO 13485:2016

    Diane Hunt, Aug 28, 2018
    Replies:
    4
    Views:
    1,429
    Diane Hunt
    Aug 29, 2018
  4. Jantani1275

    Quality performing manufacturing

    Jantani1275, Apr 18, 2017
    Replies:
    1
    Views:
    673
    yodon
    Apr 18, 2017
  5. Steve Kent

    Quality Agreement

    Steve Kent, Mar 2, 2016
    Replies:
    3
    Views:
    1,469
    Marcelo Antunes
    Mar 4, 2016
  6. Abdullah

    Qualification of HVAC system

    Abdullah, Dec 27, 2015
    Replies:
    9
    Views:
    1,387
    Jennifer Kirley
    Dec 29, 2015
  7. Rotciv

    QMS/DMS for an IT company

    Rotciv, Jan 28, 2020
    Replies:
    2
    Views:
    547
    Rotciv
    Jan 28, 2020
  8. K Muela

    Purchasing data review requirements

    K Muela, Apr 26, 2016
    Replies:
    4
    Views:
    1,367
    matkins151
    Apr 28, 2016
  9. RICHARD GALLAGHER

    Product Design Project Checklist?

    RICHARD GALLAGHER, Dec 11, 2015
    Replies:
    10
    Views:
    2,969
    QAengineer13
    Feb 3, 2016
  10. Lindy

    Procedure Deviations

    Lindy, Feb 1, 2019
    Replies:
    3
    Views:
    728
    Andy Nichols
    Feb 1, 2019
  11. Jimbo11

    Preparation For Upcoming External Audit 13485

    Jimbo11, Sep 3, 2018
    Replies:
    3
    Views:
    930
    Andy Nichols
    Sep 4, 2018
  12. Renaz

    PFMEA in low volume medical device manufacturing

    Renaz, Oct 20, 2018
    Replies:
    2
    Views:
    922
    John C. Abnet
    Oct 22, 2018
  13. Lindy

    On-site Supplier Audit Checklist

    Lindy, Jan 31, 2018
    Replies:
    7
    Views:
    3,319
    RoxaneB
    Apr 9, 2018
  14. DarisQ

    New chapter 4.2.3 Medical Device file

    DarisQ, May 9, 2016
    Replies:
    4
    Views:
    4,841
    TerryMc
    Jul 15, 2016
  15. ankit

    Need this standard-Help

    ankit, Oct 11, 2017
    Replies:
    1
    Views:
    745
    Atul Khandekar
    Oct 11, 2017
  16. Jonathan Wilkie

    NB's auditing practice called into question...

    Jonathan Wilkie, Jan 19, 2016
    Replies:
    4
    Views:
    1,616
    Jonathan Wilkie
    Jan 20, 2016
  17. 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
  18. Eloisa Hufana

    Mobile Scooters Classification

    Eloisa Hufana, Feb 13, 2024
    Replies:
    2
    Views:
    407
    Eloisa Hufana
    Feb 19, 2024
  19. John C. Abnet

    Medical device Non-conformance based on ISO 14971 ?

    John C. Abnet, Nov 30, 2021
    Replies:
    5
    Views:
    761
    John C. Abnet
    Dec 1, 2021
  20. Lindy

    MDSAP Registrar

    Lindy, Jan 18, 2019
    Replies:
    4
    Views:
    940
    Kymberly
    May 2, 2020
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