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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. Ana Silva

    ISO13485: Marketing materials and design files

    Ana Silva, Aug 24, 2021
    Replies:
    3
    Views:
    1,338
    Ana Silva
    Aug 24, 2021
  2. Stephen Lennon

    ISO 13485:2016 clause 8.2.4

    Stephen Lennon, Feb 16, 2021
    Replies:
    3
    Views:
    1,721
    Andy Nichols
    Feb 16, 2021
  3. Lindy

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

    Lindy, Apr 17, 2019
    Replies:
    3
    Views:
    1,424
    Andy Nichols
    Apr 26, 2019
  4. Susan7

    Supply for Medical Device - ISO 13485

    Susan7, Mar 21, 2019
    Replies:
    3
    Views:
    836
    tony s
    Mar 22, 2019
  5. Lindy

    Procedure Deviations

    Lindy, Feb 1, 2019
    Replies:
    3
    Views:
    741
    Andy Nichols
    Feb 1, 2019
  6. Jimbo11

    Preparation For Upcoming External Audit 13485

    Jimbo11, Sep 3, 2018
    Replies:
    3
    Views:
    942
    Andy Nichols
    Sep 4, 2018
  7. karenlin

    Every change required communication?

    karenlin, Apr 8, 2016
    Replies:
    3
    Views:
    1,096
    Jose Ramon Salazar
    Jun 20, 2017
  8. Nash Jan

    ISO 10993-1: 2009 Annex A Biological Evaluation Tests

    Nash Jan, Feb 15, 2016
    Replies:
    3
    Views:
    2,740
    RW Soller
    Feb 14, 2017
  9. Nikki

    Do we have to validate every piece of new equipment?

    Nikki, Apr 18, 2016
    Replies:
    3
    Views:
    2,097
    Karl76
    Apr 29, 2016
  10. Steve Kent

    Quality Agreement

    Steve Kent, Mar 2, 2016
    Replies:
    3
    Views:
    1,497
    Marcelo Antunes
    Mar 4, 2016
  11. QVarus

    Connecting Complaints and Risk Analysis

    QVarus, Aug 11, 2015
    Replies:
    3
    Views:
    1,013
    OrangeIsEnergy
    Aug 24, 2015
  12. Jeremy B Maher

    ISO13485 Clause 8.3 and Sub-Clause 8.3.2 and 8.3.3

    Jeremy B Maher, Oct 26, 2023
    Replies:
    4
    Views:
    776
    Andy Nichols
    Nov 1, 2023
  13. KD Shah

    How to get ISO 13485

    KD Shah, Dec 6, 2019
    Replies:
    4
    Views:
    1,034
    ValeriaGar
    Nov 3, 2020
  14. Lindy

    MDSAP Registrar

    Lindy, Jan 18, 2019
    Replies:
    4
    Views:
    957
    Kymberly
    May 2, 2020
  15. Nikki

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

    Nikki, Sep 25, 2018
    Replies:
    4
    Views:
    1,370
    tony s
    Mar 22, 2019
  16. Karly Chester Etzel

    Design and Development Plan

    Karly Chester Etzel, Sep 25, 2018
    Replies:
    4
    Views:
    1,394
    Karly Chester Etzel
    Oct 9, 2018
  17. Diane Hunt

    Question on One Sentence in 7.1 of ISO 13485:2016

    Diane Hunt, Aug 28, 2018
    Replies:
    4
    Views:
    1,452
    Diane Hunt
    Aug 29, 2018
  18. Lindy

    Real Registrar?

    Lindy, Apr 16, 2018
    Replies:
    4
    Views:
    1,041
    Andy Nichols
    Apr 16, 2018
  19. James Elwood

    13485 and Signed Documents

    James Elwood, Apr 25, 2017
    Replies:
    4
    Views:
    1,279
    Quality Manager Liz
    Nov 24, 2017
  20. DarisQ

    New chapter 4.2.3 Medical Device file

    DarisQ, May 9, 2016
    Replies:
    4
    Views:
    4,864
    TerryMc
    Jul 15, 2016
Showing threads 41 to 60 of 105

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