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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. ASFAR _to_ISOFDA

    FDA & ISO 13485 Customer Supplied Material

    ASFAR _to_ISOFDA, Jun 8, 2017
    Replies:
    1
    Views:
    735
    yodon
    Jun 9, 2017
  2. karenlin

    Every change required communication?

    karenlin, Apr 8, 2016
    Replies:
    3
    Views:
    1,076
    Jose Ramon Salazar
    Jun 20, 2017
  3. Nikki

    How do I validate our ERP system?

    Nikki, Apr 12, 2016
    Replies:
    6
    Views:
    4,963
    AcTouch
    Aug 14, 2017
  4. GregL

    ISO 13485: Suppliers to Medical Device company

    GregL, Dec 6, 2016
    Replies:
    8
    Views:
    3,237
    indicator
    Sep 7, 2017
  5. ChuckD

    Assigning Serial number at final QC check

    ChuckD, Sep 1, 2017
    Replies:
    2
    Views:
    876
    indicator
    Sep 7, 2017
  6. ankit

    Need this standard-Help

    ankit, Oct 11, 2017
    Replies:
    1
    Views:
    745
    Atul Khandekar
    Oct 11, 2017
  7. Qualityforum Mainar

    Does 13485:2016 - 7.2.3 Customer Communication include marketing?

    Qualityforum Mainar, Nov 10, 2017
    Replies:
    1
    Views:
    1,337
    yodon
    Nov 15, 2017
  8. Mohsin Farooqui

    Scoping Validation for Incoming Inspection Tools/Equipment

    Mohsin Farooqui, Nov 16, 2017
    Replies:
    1
    Views:
    1,235
    Vintage Goose
    Nov 17, 2017
  9. James Elwood

    13485 and Signed Documents

    James Elwood, Apr 25, 2017
    Replies:
    4
    Views:
    1,262
    Quality Manager Liz
    Nov 24, 2017
  10. Lindy

    Correcting Audit Findings

    Lindy, Jan 10, 2018 ... 2
    Replies:
    25
    Views:
    3,477
    BradM
    Jan 25, 2018
  11. MarkMeer

    What's the deal with MDSAP?

    MarkMeer, Dec 11, 2015
    Replies:
    11
    Views:
    2,910
    Lindy
    Jan 26, 2018
  12. Udirn1

    Spare parts

    Udirn1, Feb 7, 2018
    Replies:
    1
    Views:
    659
    Vintage Goose
    Feb 15, 2018
  13. Lindy

    On-site Supplier Audit Checklist

    Lindy, Jan 31, 2018
    Replies:
    7
    Views:
    3,315
    RoxaneB
    Apr 9, 2018
  14. Lindy

    Real Registrar?

    Lindy, Apr 16, 2018
    Replies:
    4
    Views:
    1,023
    Andy Nichols
    Apr 16, 2018
  15. Nikki

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

    Nikki, Jun 18, 2018
    Replies:
    7
    Views:
    2,859
    John C. Abnet
    Jun 19, 2018
  16. Diane Hunt

    Question on One Sentence in 7.1 of ISO 13485:2016

    Diane Hunt, Aug 28, 2018
    Replies:
    4
    Views:
    1,427
    Diane Hunt
    Aug 29, 2018
  17. Jimbo11

    Preparation For Upcoming External Audit 13485

    Jimbo11, Sep 3, 2018
    Replies:
    3
    Views:
    929
    Andy Nichols
    Sep 4, 2018
  18. Karly Chester Etzel

    Design and Development Plan

    Karly Chester Etzel, Sep 25, 2018
    Replies:
    4
    Views:
    1,362
    Karly Chester Etzel
    Oct 9, 2018
  19. Renaz

    PFMEA in low volume medical device manufacturing

    Renaz, Oct 20, 2018
    Replies:
    2
    Views:
    922
    John C. Abnet
    Oct 22, 2018
  20. Greig

    ISO13485 - The correct standard for pharmaceutical packaging?

    Greig, Jul 3, 2018
    Replies:
    6
    Views:
    3,129
    Greig
    Nov 28, 2018
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