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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:
    2,592
    Maryna
    Jun 9, 2020
  2. yzl1018

    Is there any Brazilian biosafety standard or regulation?

    yzl1018, Dec 18, 2021
    Replies:
    0
    Views:
    1,839
    yzl1018
    Dec 18, 2021
  3. HeathW

    Is validation of training tools required?

    HeathW, Mar 26, 2021
    Replies:
    5
    Views:
    905
    HeathW
    Apr 1, 2021
  4. Nash Jan

    ISO 10993-1: 2009 Annex A Biological Evaluation Tests

    Nash Jan, Feb 15, 2016
    Replies:
    3
    Views:
    2,734
    RW Soller
    Feb 14, 2017
  5. Kishnu Vaarma ROSS

    ISO 13485

    Kishnu Vaarma ROSS, Nov 3, 2022
    Replies:
    3
    Views:
    1,886
    Kishnu Vaarma ROSS
    Nov 14, 2022
  6. S. Desai

    ISO 13485 - New Facility Question

    S. Desai, Jan 27, 2016
    Replies:
    2
    Views:
    1,052
    S. Desai
    Jan 28, 2016
  7. Jura1752

    ISO 13485 7.4.1 Purchasing Process

    Jura1752, Aug 7, 2016
    Replies:
    1
    Views:
    2,182
    yodon
    Aug 8, 2016
  8. QA Bee

    ISO 13485 Pre-Assessment

    QA Bee, Feb 11, 2016
    Replies:
    4
    Views:
    1,265
    QA Bee
    Feb 11, 2016
  9. Marcelo Antunes

    ISO 13485 Revision

    Marcelo Antunes, Aug 25, 2015 ... 2 3 4
    Replies:
    65
    Views:
    12,049
    Sue Place
    Apr 25, 2016
  10. PoojaN

    ISO 13485 vs CFR 820

    PoojaN, May 26, 2016
    Replies:
    4
    Views:
    1,321
    Marc Smith
    May 27, 2016
  11. QA Bee

    ISO 13485 vs. EN ISO 13485

    QA Bee, Mar 14, 2016
    Replies:
    4
    Views:
    20,546
    Pads38
    Mar 15, 2016
  12. Somashekar

    ISO 13485. The next revision.

    Somashekar, Aug 2, 2015
    Replies:
    4
    Views:
    1,481
    Candi1024
    Aug 7, 2015
  13. Dave L.

    ISO 13485/21 CFR 820 Awareness/Orientation

    Dave L., Sep 1, 2015
    Replies:
    4
    Views:
    1,211
    Dave L.
    Sep 1, 2015
  14. GregL

    ISO 13485: Suppliers to Medical Device company

    GregL, Dec 6, 2016
    Replies:
    8
    Views:
    3,249
    indicator
    Sep 7, 2017
  15. Stephen Lennon

    ISO 13485:2016 clause 8.2.4

    Stephen Lennon, Feb 16, 2021
    Replies:
    3
    Views:
    1,657
    Andy Nichols
    Feb 16, 2021
  16. Lindy

    ISO 13485:2016 Procedures in China

    Lindy, Nov 4, 2019
    Replies:
    1
    Views:
    765
    Golfman25
    Nov 4, 2019
  17. Greig

    ISO13485 - The correct standard for pharmaceutical packaging?

    Greig, Jul 3, 2018
    Replies:
    6
    Views:
    3,155
    Greig
    Nov 28, 2018
  18. 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:
    750
    Andy Nichols
    Nov 1, 2023
  19. Ana Silva

    ISO13485: Marketing materials and design files

    Ana Silva, Aug 24, 2021
    Replies:
    3
    Views:
    1,317
    Ana Silva
    Aug 24, 2021
  20. neil300n

    Job opportunity - ISO 13485 Quality Compliance Officer, London

    neil300n, Dec 31, 2020
    Replies:
    0
    Views:
    694
    neil300n
    Dec 31, 2020
Showing threads 41 to 60 of 105

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