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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:
    1,479
    Candi1024
    Aug 7, 2015
  2. OrangeIsEnergy

    Document & record retention times

    OrangeIsEnergy, Aug 10, 2015
    Replies:
    10
    Views:
    9,300
    OrangeIsEnergy
    Aug 13, 2015
  3. QVarus

    Connecting Complaints and Risk Analysis

    QVarus, Aug 11, 2015
    Replies:
    3
    Views:
    1,007
    OrangeIsEnergy
    Aug 24, 2015
  4. Dave L.

    ISO 13485/21 CFR 820 Awareness/Orientation

    Dave L., Sep 1, 2015
    Replies:
    4
    Views:
    1,208
    Dave L.
    Sep 1, 2015
  5. 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
  6. Nash Jan

    LAL Testing Frequency

    Nash Jan, Sep 17, 2015
    Replies:
    4
    Views:
    1,782
    Nash Jan
    Sep 18, 2015
  7. Make-it-simple

    Corrective and/or Preventive Action Procedure

    Make-it-simple, Oct 2, 2015
    Replies:
    5
    Views:
    1,743
    Nikki
    Oct 5, 2015
  8. JCIC49

    Use of Sharepoint for controlling documents

    JCIC49, Nov 27, 2015
    Replies:
    6
    Views:
    2,001
    Claes Gefvenberg
    Dec 1, 2015
  9. Mandy

    How often to calibrate an analytical balance

    Mandy, Dec 6, 2015
    Replies:
    1
    Views:
    732
    Eric Twiname
    Dec 7, 2015
  10. Abdullah

    Qualification of HVAC system

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

    AQL

    Abdullah, Dec 28, 2015
    Replies:
    9
    Views:
    3,333
    DavidD
    Jan 5, 2016
  12. QA Bee

    Risk Management Process

    QA Bee, Jan 5, 2016
    Replies:
    4
    Views:
    897
    QA Bee
    Jan 6, 2016
  13. Rahul

    FDA registration and ISO 13485 recertification

    Rahul, Jan 5, 2016
    Replies:
    4
    Views:
    1,018
    Jim Hagenbaugh
    Jan 8, 2016
  14. Jonathan Wilkie

    NB's auditing practice called into question...

    Jonathan Wilkie, Jan 19, 2016
    Replies:
    4
    Views:
    1,616
    Jonathan Wilkie
    Jan 20, 2016
  15. Nikki

    Can I Exclude These 13485 requirements?

    Nikki, Jan 28, 2016
    Replies:
    1
    Views:
    766
    Ronen E
    Jan 28, 2016
  16. S. Desai

    ISO 13485 - New Facility Question

    S. Desai, Jan 27, 2016
    Replies:
    2
    Views:
    1,049
    S. Desai
    Jan 28, 2016
  17. pcmc47

    Removing Non Value Added Inspection

    pcmc47, Jan 29, 2016
    Replies:
    2
    Views:
    1,043
    Bev D
    Jan 29, 2016
  18. Nomi P

    Equipment SOPs

    Nomi P, Jan 28, 2016
    Replies:
    1
    Views:
    1,108
    yodon
    Jan 29, 2016
  19. Louise

    Critical Supplier Agreement

    Louise, Feb 1, 2016
    Replies:
    0
    Views:
    883
    Louise
    Feb 1, 2016
  20. RICHARD GALLAGHER

    Product Design Project Checklist?

    RICHARD GALLAGHER, Dec 11, 2015
    Replies:
    10
    Views:
    2,969
    QAengineer13
    Feb 3, 2016
Showing threads 1 to 20 of 104

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