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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. AdaTW22

    Is a software platform a medical device???

    AdaTW22, Mar 9, 2020
    Replies:
    2
    Views:
    2,590
    Maryna
    Jun 9, 2020
  2. Jura1752

    ISO 13485 7.4.1 Purchasing Process

    Jura1752, Aug 7, 2016
    Replies:
    1
    Views:
    2,178
    yodon
    Aug 8, 2016
  3. Nikki

    Do we have to validate every piece of new equipment?

    Nikki, Apr 18, 2016
    Replies:
    3
    Views:
    2,072
    Karl76
    Apr 29, 2016
  4. JCIC49

    Use of Sharepoint for controlling documents

    JCIC49, Nov 27, 2015
    Replies:
    6
    Views:
    2,010
    Claes Gefvenberg
    Dec 1, 2015
  5. Kishnu Vaarma ROSS

    ISO 13485

    Kishnu Vaarma ROSS, Nov 3, 2022
    Replies:
    3
    Views:
    1,885
    Kishnu Vaarma ROSS
    Nov 14, 2022
  6. yzl1018

    Is there any Brazilian biosafety standard or regulation?

    yzl1018, Dec 18, 2021
    Replies:
    0
    Views:
    1,837
    yzl1018
    Dec 18, 2021
  7. Nikki

    Should we keep ISO 9001:2015 when we go for 13485 certification?

    Nikki, Jan 18, 2016
    Replies:
    8
    Views:
    1,816
    Scott K
    Feb 9, 2016
  8. Nikki

    What is missing from my list for 13485 certification?

    Nikki, May 27, 2016
    Replies:
    9
    Views:
    1,793
    Vintage Goose
    Nov 23, 2016
  9. Nash Jan

    LAL Testing Frequency

    Nash Jan, Sep 17, 2015
    Replies:
    4
    Views:
    1,783
    Nash Jan
    Sep 18, 2015
  10. Make-it-simple

    Corrective and/or Preventive Action Procedure

    Make-it-simple, Oct 2, 2015
    Replies:
    5
    Views:
    1,746
    Nikki
    Oct 5, 2015
  11. Nikki

    Looking to impress at new job

    Nikki, Aug 25, 2020
    Replies:
    13
    Views:
    1,690
    Andy Nichols
    Oct 15, 2020
  12. Stephen Lennon

    ISO 13485:2016 clause 8.2.4

    Stephen Lennon, Feb 16, 2021
    Replies:
    3
    Views:
    1,648
    Andy Nichols
    Feb 16, 2021
  13. Jonathan Wilkie

    NB's auditing practice called into question...

    Jonathan Wilkie, Jan 19, 2016
    Replies:
    4
    Views:
    1,623
    Jonathan Wilkie
    Jan 20, 2016
  14. Nikki

    13485:2016 Internal Auditing Online Course?

    Nikki, Mar 8, 2019
    Replies:
    7
    Views:
    1,612
    Chaitany Thaker
    Apr 15, 2019
  15. Luca Ercolani

    Adobe Sign as digital signature tool

    Luca Ercolani, Jun 8, 2020
    Replies:
    2
    Views:
    1,574
    Steven Severt
    Sep 19, 2020
  16. Somashekar

    ISO 13485. The next revision.

    Somashekar, Aug 2, 2015
    Replies:
    4
    Views:
    1,481
    Candi1024
    Aug 7, 2015
  17. Steve Kent

    Quality Agreement

    Steve Kent, Mar 2, 2016
    Replies:
    3
    Views:
    1,474
    Marcelo Antunes
    Mar 4, 2016
  18. Diane Hunt

    Question on One Sentence in 7.1 of ISO 13485:2016

    Diane Hunt, Aug 28, 2018
    Replies:
    4
    Views:
    1,434
    Diane Hunt
    Aug 29, 2018
  19. Lindy

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

    Lindy, Apr 17, 2019
    Replies:
    3
    Views:
    1,419
    Andy Nichols
    Apr 26, 2019
  20. Abdullah

    Qualification of HVAC system

    Abdullah, Dec 27, 2015
    Replies:
    9
    Views:
    1,395
    Jennifer Kirley
    Dec 29, 2015
Showing threads 21 to 40 of 105

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