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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. Somashekar

    ISO 13485. The next revision.

    Somashekar, Aug 2, 2015
    Replies:
    4
    Views:
    1,481
    Candi1024
    Aug 7, 2015
  2. OrangeIsEnergy

    Document & record retention times

    OrangeIsEnergy, Aug 10, 2015
    Replies:
    10
    Views:
    9,308
    OrangeIsEnergy
    Aug 13, 2015
  3. QVarus

    Connecting Complaints and Risk Analysis

    QVarus, Aug 11, 2015
    Replies:
    3
    Views:
    1,008
    OrangeIsEnergy
    Aug 24, 2015
  4. Marcelo Antunes

    ISO 13485 Revision

    Marcelo Antunes, Aug 25, 2015 ... 2 3 4
    Replies:
    65
    Views:
    12,029
    Sue Place
    Apr 25, 2016
  5. Dave L.

    ISO 13485/21 CFR 820 Awareness/Orientation

    Dave L., Sep 1, 2015
    Replies:
    4
    Views:
    1,210
    Dave L.
    Sep 1, 2015
  6. 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:
    1,383
    Rachel
    Sep 8, 2015
  7. Nash Jan

    LAL Testing Frequency

    Nash Jan, Sep 17, 2015
    Replies:
    4
    Views:
    1,783
    Nash Jan
    Sep 18, 2015
  8. Make-it-simple

    Corrective and/or Preventive Action Procedure

    Make-it-simple, Oct 2, 2015
    Replies:
    5
    Views:
    1,745
    Nikki
    Oct 5, 2015
  9. JCIC49

    Use of Sharepoint for controlling documents

    JCIC49, Nov 27, 2015
    Replies:
    6
    Views:
    2,007
    Claes Gefvenberg
    Dec 1, 2015
  10. Nikki

    How much work to get to 13485 from ISO 9001:2015?

    Nikki, Dec 4, 2015 ... 2
    Replies:
    23
    Views:
    3,218
    John C. Abnet
    Nov 5, 2020
  11. Mandy

    How often to calibrate an analytical balance

    Mandy, Dec 6, 2015
    Replies:
    1
    Views:
    734
    Eric Twiname
    Dec 7, 2015
  12. RICHARD GALLAGHER

    Product Design Project Checklist?

    RICHARD GALLAGHER, Dec 11, 2015
    Replies:
    10
    Views:
    2,975
    QAengineer13
    Feb 3, 2016
  13. MarkMeer

    What's the deal with MDSAP?

    MarkMeer, Dec 11, 2015
    Replies:
    11
    Views:
    2,914
    Lindy
    Jan 26, 2018
  14. Abdullah

    Qualification of HVAC system

    Abdullah, Dec 27, 2015
    Replies:
    9
    Views:
    1,395
    Jennifer Kirley
    Dec 29, 2015
  15. Abdullah

    AQL

    Abdullah, Dec 28, 2015
    Replies:
    9
    Views:
    3,337
    DavidD
    Jan 5, 2016
  16. QA Bee

    Risk Management Process

    QA Bee, Jan 5, 2016
    Replies:
    4
    Views:
    899
    QA Bee
    Jan 6, 2016
  17. Rahul

    FDA registration and ISO 13485 recertification

    Rahul, Jan 5, 2016
    Replies:
    4
    Views:
    1,019
    Jim Hagenbaugh
    Jan 8, 2016
  18. Nikki

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

    Nikki, Jan 18, 2016
    Replies:
    8
    Views:
    1,815
    Scott K
    Feb 9, 2016
  19. Jonathan Wilkie

    NB's auditing practice called into question...

    Jonathan Wilkie, Jan 19, 2016
    Replies:
    4
    Views:
    1,622
    Jonathan Wilkie
    Jan 20, 2016
  20. S. Desai

    ISO 13485 - New Facility Question

    S. Desai, Jan 27, 2016
    Replies:
    2
    Views:
    1,051
    S. Desai
    Jan 28, 2016
Showing threads 1 to 20 of 104

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