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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. Diane Hunt

    Question on One Sentence in 7.1 of ISO 13485:2016

    Diane Hunt, Aug 28, 2018
    Replies:
    4
    Views:
    1,423
    Diane Hunt
    Aug 29, 2018
  2. Lindy

    Real Registrar?

    Lindy, Apr 16, 2018
    Replies:
    4
    Views:
    1,021
    Andy Nichols
    Apr 16, 2018
  3. James Elwood

    13485 and Signed Documents

    James Elwood, Apr 25, 2017
    Replies:
    4
    Views:
    1,258
    Quality Manager Liz
    Nov 24, 2017
  4. DarisQ

    New chapter 4.2.3 Medical Device file

    DarisQ, May 9, 2016
    Replies:
    4
    Views:
    4,838
    TerryMc
    Jul 15, 2016
  5. PoojaN

    ISO 13485 vs CFR 820

    PoojaN, May 26, 2016
    Replies:
    4
    Views:
    1,308
    Marc Smith
    May 27, 2016
  6. K Muela

    Purchasing data review requirements

    K Muela, Apr 26, 2016
    Replies:
    4
    Views:
    1,352
    matkins151
    Apr 28, 2016
  7. QA Bee

    ISO 13485 vs. EN ISO 13485

    QA Bee, Mar 14, 2016
    Replies:
    4
    Views:
    20,490
    Pads38
    Mar 15, 2016
  8. QA Bee

    ISO 13485 Pre-Assessment

    QA Bee, Feb 11, 2016
    Replies:
    4
    Views:
    1,263
    QA Bee
    Feb 11, 2016
  9. Jonathan Wilkie

    NB's auditing practice called into question...

    Jonathan Wilkie, Jan 19, 2016
    Replies:
    4
    Views:
    1,614
    Jonathan Wilkie
    Jan 20, 2016
  10. Rahul

    FDA registration and ISO 13485 recertification

    Rahul, Jan 5, 2016
    Replies:
    4
    Views:
    1,014
    Jim Hagenbaugh
    Jan 8, 2016
  11. QA Bee

    Risk Management Process

    QA Bee, Jan 5, 2016
    Replies:
    4
    Views:
    896
    QA Bee
    Jan 6, 2016
  12. Nash Jan

    LAL Testing Frequency

    Nash Jan, Sep 17, 2015
    Replies:
    4
    Views:
    1,778
    Nash Jan
    Sep 18, 2015
  13. Dave L.

    ISO 13485/21 CFR 820 Awareness/Orientation

    Dave L., Sep 1, 2015
    Replies:
    4
    Views:
    1,204
    Dave L.
    Sep 1, 2015
  14. Somashekar

    ISO 13485. The next revision.

    Somashekar, Aug 2, 2015
    Replies:
    4
    Views:
    1,477
    Candi1024
    Aug 7, 2015
  15. Kishnu Vaarma ROSS

    ISO 13485

    Kishnu Vaarma ROSS, Nov 3, 2022
    Replies:
    3
    Views:
    1,875
    Kishnu Vaarma ROSS
    Nov 14, 2022
  16. Ana Silva

    ISO13485: Marketing materials and design files

    Ana Silva, Aug 24, 2021
    Replies:
    3
    Views:
    1,308
    Ana Silva
    Aug 24, 2021
  17. Stephen Lennon

    ISO 13485:2016 clause 8.2.4

    Stephen Lennon, Feb 16, 2021
    Replies:
    3
    Views:
    1,609
    Andy Nichols
    Feb 16, 2021
  18. Lindy

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

    Lindy, Apr 17, 2019
    Replies:
    3
    Views:
    1,411
    Andy Nichols
    Apr 26, 2019
  19. Susan7

    Supply for Medical Device - ISO 13485

    Susan7, Mar 21, 2019
    Replies:
    3
    Views:
    823
    tony s
    Mar 22, 2019
  20. Lindy

    Procedure Deviations

    Lindy, Feb 1, 2019
    Replies:
    3
    Views:
    726
    Andy Nichols
    Feb 1, 2019
Showing threads 41 to 60 of 103

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