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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. fialor

    Country of Origin or "Made In" Tags

    fialor, Sep 14, 2016
    Replies:
    2
    Views:
    879
    RoxaneB
    Sep 14, 2016
  2. MonteS

    Must Medical Device Subcomponent Manufacturers Perform IQs and OQs on Existing Equipment?

    MonteS, Sep 27, 2016
    Replies:
    2
    Views:
    958
    Candi1024
    Oct 11, 2016
  3. GregL

    ISO 13485: Suppliers to Medical Device company

    GregL, Dec 6, 2016
    Replies:
    8
    Views:
    3,264
    indicator
    Sep 7, 2017
  4. Mike Bodine

    Understanding the difference between ISO 13485 and 21 CFR 820

    Mike Bodine, Jan 25, 2017
    Replies:
    5
    Views:
    2,652
    ValeriaGar
    Nov 3, 2020
  5. Jose Ramon Salazar

    Calibrating maintenance equipment

    Jose Ramon Salazar, Feb 3, 2017
    Replies:
    9
    Views:
    3,799
    ncwalker
    Feb 14, 2017
  6. Jantani1275

    Quality performing manufacturing

    Jantani1275, Apr 18, 2017
    Replies:
    1
    Views:
    685
    yodon
    Apr 18, 2017
  7. James Elwood

    13485 and Signed Documents

    James Elwood, Apr 25, 2017
    Replies:
    4
    Views:
    1,279
    Quality Manager Liz
    Nov 24, 2017
  8. ASFAR _to_ISOFDA

    FDA & ISO 13485 Customer Supplied Material

    ASFAR _to_ISOFDA, Jun 8, 2017
    Replies:
    1
    Views:
    742
    yodon
    Jun 9, 2017
  9. ChuckD

    Assigning Serial number at final QC check

    ChuckD, Sep 1, 2017
    Replies:
    2
    Views:
    893
    indicator
    Sep 7, 2017
  10. ankit

    Need this standard-Help

    ankit, Oct 11, 2017
    Replies:
    1
    Views:
    750
    Atul Khandekar
    Oct 11, 2017
  11. Qualityforum Mainar

    Does 13485:2016 - 7.2.3 Customer Communication include marketing?

    Qualityforum Mainar, Nov 10, 2017
    Replies:
    1
    Views:
    1,390
    yodon
    Nov 15, 2017
  12. Mohsin Farooqui

    Scoping Validation for Incoming Inspection Tools/Equipment

    Mohsin Farooqui, Nov 16, 2017
    Replies:
    1
    Views:
    1,247
    Vintage Goose
    Nov 17, 2017
  13. Lindy

    Correcting Audit Findings

    Lindy, Jan 10, 2018 ... 2
    Replies:
    25
    Views:
    3,631
    BradM
    Jan 25, 2018
  14. Lindy

    On-site Supplier Audit Checklist

    Lindy, Jan 31, 2018
    Replies:
    7
    Views:
    3,413
    RoxaneB
    Apr 9, 2018
  15. Udirn1

    Spare parts

    Udirn1, Feb 7, 2018
    Replies:
    1
    Views:
    666
    Vintage Goose
    Feb 15, 2018
  16. Lindy

    Real Registrar?

    Lindy, Apr 16, 2018
    Replies:
    4
    Views:
    1,041
    Andy Nichols
    Apr 16, 2018
  17. Nikki

    GDP - Having to give a reason to use N/A?

    Nikki, Jun 18, 2018
    Replies:
    7
    Views:
    2,925
    John C. Abnet
    Jun 19, 2018
  18. Greig

    ISO13485 - The correct standard for pharmaceutical packaging?

    Greig, Jul 3, 2018
    Replies:
    6
    Views:
    3,189
    Greig
    Nov 28, 2018
  19. 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
  20. Jimbo11

    Preparation For Upcoming External Audit 13485

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