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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. Renaz

    PFMEA in low volume medical device manufacturing

    Renaz, Oct 20, 2018
    Replies:
    2
    Views:
    920
    John C. Abnet
    Oct 22, 2018
  2. Nikki

    Updating QM to 13485:2016 - We do not make medical devices

    Nikki, Sep 25, 2018
    Replies:
    4
    Views:
    1,354
    tony s
    Mar 22, 2019
  3. Karly Chester Etzel

    Design and Development Plan

    Karly Chester Etzel, Sep 25, 2018
    Replies:
    4
    Views:
    1,357
    Karly Chester Etzel
    Oct 9, 2018
  4. Jimbo11

    Preparation For Upcoming External Audit 13485

    Jimbo11, Sep 3, 2018
    Replies:
    3
    Views:
    927
    Andy Nichols
    Sep 4, 2018
  5. Diane Hunt

    Question on One Sentence in 7.1 of ISO 13485:2016

    Diane Hunt, Aug 28, 2018
    Replies:
    4
    Views:
    1,424
    Diane Hunt
    Aug 29, 2018
  6. Greig

    ISO13485 - The correct standard for pharmaceutical packaging?

    Greig, Jul 3, 2018
    Replies:
    6
    Views:
    3,120
    Greig
    Nov 28, 2018
  7. Nikki

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

    Nikki, Jun 18, 2018
    Replies:
    7
    Views:
    2,849
    John C. Abnet
    Jun 19, 2018
  8. Lindy

    Real Registrar?

    Lindy, Apr 16, 2018
    Replies:
    4
    Views:
    1,022
    Andy Nichols
    Apr 16, 2018
  9. Udirn1

    Spare parts

    Udirn1, Feb 7, 2018
    Replies:
    1
    Views:
    658
    Vintage Goose
    Feb 15, 2018
  10. Lindy

    On-site Supplier Audit Checklist

    Lindy, Jan 31, 2018
    Replies:
    7
    Views:
    3,301
    RoxaneB
    Apr 9, 2018
  11. Lindy

    Correcting Audit Findings

    Lindy, Jan 10, 2018 ... 2
    Replies:
    25
    Views:
    3,450
    BradM
    Jan 25, 2018
  12. Mohsin Farooqui

    Scoping Validation for Incoming Inspection Tools/Equipment

    Mohsin Farooqui, Nov 16, 2017
    Replies:
    1
    Views:
    1,234
    Vintage Goose
    Nov 17, 2017
  13. Qualityforum Mainar

    Does 13485:2016 - 7.2.3 Customer Communication include marketing?

    Qualityforum Mainar, Nov 10, 2017
    Replies:
    1
    Views:
    1,325
    yodon
    Nov 15, 2017
  14. ankit

    Need this standard-Help

    ankit, Oct 11, 2017
    Replies:
    1
    Views:
    741
    Atul Khandekar
    Oct 11, 2017
  15. ChuckD

    Assigning Serial number at final QC check

    ChuckD, Sep 1, 2017
    Replies:
    2
    Views:
    875
    indicator
    Sep 7, 2017
  16. ASFAR _to_ISOFDA

    FDA & ISO 13485 Customer Supplied Material

    ASFAR _to_ISOFDA, Jun 8, 2017
    Replies:
    1
    Views:
    734
    yodon
    Jun 9, 2017
  17. James Elwood

    13485 and Signed Documents

    James Elwood, Apr 25, 2017
    Replies:
    4
    Views:
    1,258
    Quality Manager Liz
    Nov 24, 2017
  18. Jantani1275

    Quality performing manufacturing

    Jantani1275, Apr 18, 2017
    Replies:
    1
    Views:
    671
    yodon
    Apr 18, 2017
  19. Jose Ramon Salazar

    Calibrating maintenance equipment

    Jose Ramon Salazar, Feb 3, 2017
    Replies:
    9
    Views:
    3,710
    ncwalker
    Feb 14, 2017
  20. Mike Bodine

    Understanding the difference between ISO 13485 and 21 CFR 820

    Mike Bodine, Jan 25, 2017
    Replies:
    5
    Views:
    2,585
    ValeriaGar
    Nov 3, 2020
Showing threads 41 to 60 of 103

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