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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. QA Bee

    ISO 13485 vs. EN ISO 13485

    QA Bee, Mar 14, 2016
    Replies:
    4
    Views:
    20,518
    Pads38
    Mar 15, 2016
  2. Steve Kent

    Quality Agreement

    Steve Kent, Mar 2, 2016
    Replies:
    3
    Views:
    1,468
    Marcelo Antunes
    Mar 4, 2016
  3. QA Bee

    ISO 13485 Pre-Assessment

    QA Bee, Feb 11, 2016
    Replies:
    4
    Views:
    1,264
    QA Bee
    Feb 11, 2016
  4. Nikki

    Should we keep ISO 9001:2015 when we go for 13485 certification?

    Nikki, Jan 18, 2016
    Replies:
    8
    Views:
    1,805
    Scott K
    Feb 9, 2016
  5. RICHARD GALLAGHER

    Product Design Project Checklist?

    RICHARD GALLAGHER, Dec 11, 2015
    Replies:
    10
    Views:
    2,969
    QAengineer13
    Feb 3, 2016
  6. Louise

    Critical Supplier Agreement

    Louise, Feb 1, 2016
    Replies:
    0
    Views:
    883
    Louise
    Feb 1, 2016
  7. Nomi P

    Equipment SOPs

    Nomi P, Jan 28, 2016
    Replies:
    1
    Views:
    1,108
    yodon
    Jan 29, 2016
  8. pcmc47

    Removing Non Value Added Inspection

    pcmc47, Jan 29, 2016
    Replies:
    2
    Views:
    1,043
    Bev D
    Jan 29, 2016
  9. S. Desai

    ISO 13485 - New Facility Question

    S. Desai, Jan 27, 2016
    Replies:
    2
    Views:
    1,049
    S. Desai
    Jan 28, 2016
  10. Nikki

    Can I Exclude These 13485 requirements?

    Nikki, Jan 28, 2016
    Replies:
    1
    Views:
    766
    Ronen E
    Jan 28, 2016
  11. Jonathan Wilkie

    NB's auditing practice called into question...

    Jonathan Wilkie, Jan 19, 2016
    Replies:
    4
    Views:
    1,616
    Jonathan Wilkie
    Jan 20, 2016
  12. Rahul

    FDA registration and ISO 13485 recertification

    Rahul, Jan 5, 2016
    Replies:
    4
    Views:
    1,017
    Jim Hagenbaugh
    Jan 8, 2016
  13. QA Bee

    Risk Management Process

    QA Bee, Jan 5, 2016
    Replies:
    4
    Views:
    897
    QA Bee
    Jan 6, 2016
  14. Abdullah

    AQL

    Abdullah, Dec 28, 2015
    Replies:
    9
    Views:
    3,332
    DavidD
    Jan 5, 2016
  15. Abdullah

    Qualification of HVAC system

    Abdullah, Dec 27, 2015
    Replies:
    9
    Views:
    1,387
    Jennifer Kirley
    Dec 29, 2015
  16. Mandy

    How often to calibrate an analytical balance

    Mandy, Dec 6, 2015
    Replies:
    1
    Views:
    732
    Eric Twiname
    Dec 7, 2015
  17. JCIC49

    Use of Sharepoint for controlling documents

    JCIC49, Nov 27, 2015
    Replies:
    6
    Views:
    2,001
    Claes Gefvenberg
    Dec 1, 2015
  18. Make-it-simple

    Corrective and/or Preventive Action Procedure

    Make-it-simple, Oct 2, 2015
    Replies:
    5
    Views:
    1,742
    Nikki
    Oct 5, 2015
  19. Nash Jan

    LAL Testing Frequency

    Nash Jan, Sep 17, 2015
    Replies:
    4
    Views:
    1,780
    Nash Jan
    Sep 18, 2015
  20. Rachel

    Do we need to have the word SHALL in our QMS as it is in ISO 13485 ?

    Rachel, Sep 2, 2015
    Replies:
    5
    Views:
    1,380
    Rachel
    Sep 8, 2015
Showing threads 81 to 100 of 104

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