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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. 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
  2. Qualityforum Mainar

    Does 13485:2016 - 7.2.3 Customer Communication include marketing?

    Qualityforum Mainar, Nov 10, 2017
    Replies:
    1
    Views:
    1,394
    yodon
    Nov 15, 2017
  3. Karly Chester Etzel

    Design and Development Plan

    Karly Chester Etzel, Sep 25, 2018
    Replies:
    4
    Views:
    1,397
    Karly Chester Etzel
    Oct 9, 2018
  4. Rachel

    Do we need to have the word SHALL in our QMS as it is in ISO 13485 ?

    Rachel, Sep 2, 2015
    Replies:
    5
    Views:
    1,398
    Rachel
    Sep 8, 2015
  5. K Muela

    Purchasing data review requirements

    K Muela, Apr 26, 2016
    Replies:
    4
    Views:
    1,400
    matkins151
    Apr 28, 2016
  6. Abdullah

    Qualification of HVAC system

    Abdullah, Dec 27, 2015
    Replies:
    9
    Views:
    1,414
    Jennifer Kirley
    Dec 29, 2015
  7. Lindy

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

    Lindy, Apr 17, 2019
    Replies:
    3
    Views:
    1,425
    Andy Nichols
    Apr 26, 2019
  8. Diane Hunt

    Question on One Sentence in 7.1 of ISO 13485:2016

    Diane Hunt, Aug 28, 2018
    Replies:
    4
    Views:
    1,457
    Diane Hunt
    Aug 29, 2018
  9. Somashekar

    ISO 13485. The next revision.

    Somashekar, Aug 2, 2015
    Replies:
    4
    Views:
    1,497
    Candi1024
    Aug 7, 2015
  10. Steve Kent

    Quality Agreement

    Steve Kent, Mar 2, 2016
    Replies:
    3
    Views:
    1,501
    Marcelo Antunes
    Mar 4, 2016
  11. Luca Ercolani

    Adobe Sign as digital signature tool

    Luca Ercolani, Jun 8, 2020
    Replies:
    2
    Views:
    1,583
    Steven Severt
    Sep 19, 2020
  12. Jonathan Wilkie

    NB's auditing practice called into question...

    Jonathan Wilkie, Jan 19, 2016
    Replies:
    4
    Views:
    1,630
    Jonathan Wilkie
    Jan 20, 2016
  13. Nikki

    13485:2016 Internal Auditing Online Course?

    Nikki, Mar 8, 2019
    Replies:
    7
    Views:
    1,636
    Chaitany Thaker
    Apr 15, 2019
  14. Nikki

    Looking to impress at new job

    Nikki, Aug 25, 2020
    Replies:
    13
    Views:
    1,715
    Andy Nichols
    Oct 15, 2020
  15. Stephen Lennon

    ISO 13485:2016 clause 8.2.4

    Stephen Lennon, Feb 16, 2021
    Replies:
    3
    Views:
    1,727
    Andy Nichols
    Feb 16, 2021
  16. Make-it-simple

    Corrective and/or Preventive Action Procedure

    Make-it-simple, Oct 2, 2015
    Replies:
    5
    Views:
    1,752
    Nikki
    Oct 5, 2015
  17. Nash Jan

    LAL Testing Frequency

    Nash Jan, Sep 17, 2015
    Replies:
    4
    Views:
    1,793
    Nash Jan
    Sep 18, 2015
  18. Nikki

    What is missing from my list for 13485 certification?

    Nikki, May 27, 2016
    Replies:
    9
    Views:
    1,805
    Vintage Goose
    Nov 23, 2016
  19. 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
  20. yzl1018

    Is there any Brazilian biosafety standard or regulation?

    yzl1018, Dec 18, 2021
    Replies:
    0
    Views:
    1,847
    yzl1018
    Dec 18, 2021
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