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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. Jimbo11

    Preparation For Upcoming External Audit 13485

    Jimbo11, Sep 3, 2018
    Replies:
    3
    Views:
    936
    Andy Nichols
    Sep 4, 2018
  2. karenlin

    Every change required communication?

    karenlin, Apr 8, 2016
    Replies:
    3
    Views:
    1,078
    Jose Ramon Salazar
    Jun 20, 2017
  3. Nash Jan

    ISO 10993-1: 2009 Annex A Biological Evaluation Tests

    Nash Jan, Feb 15, 2016
    Replies:
    3
    Views:
    2,731
    RW Soller
    Feb 14, 2017
  4. Nikki

    Do we have to validate every piece of new equipment?

    Nikki, Apr 18, 2016
    Replies:
    3
    Views:
    2,068
    Karl76
    Apr 29, 2016
  5. Steve Kent

    Quality Agreement

    Steve Kent, Mar 2, 2016
    Replies:
    3
    Views:
    1,472
    Marcelo Antunes
    Mar 4, 2016
  6. QVarus

    Connecting Complaints and Risk Analysis

    QVarus, Aug 11, 2015
    Replies:
    3
    Views:
    1,008
    OrangeIsEnergy
    Aug 24, 2015
  7. Eloisa Hufana

    Mobile Scooters Classification

    Eloisa Hufana, Feb 13, 2024
    Replies:
    2
    Views:
    409
    Eloisa Hufana
    Feb 19, 2024
  8. Luca Ercolani

    Adobe Sign as digital signature tool

    Luca Ercolani, Jun 8, 2020
    Replies:
    2
    Views:
    1,574
    Steven Severt
    Sep 19, 2020
  9. duff999

    Equipment validations

    duff999, Sep 26, 2019
    Replies:
    2
    Views:
    732
    duff999
    Aug 26, 2020
  10. AdaTW22

    Is a software platform a medical device???

    AdaTW22, Mar 9, 2020
    Replies:
    2
    Views:
    2,586
    Maryna
    Jun 9, 2020
  11. Kymberly

    Review of quality records

    Kymberly, May 2, 2020
    Replies:
    2
    Views:
    661
    Andy Nichols
    May 3, 2020
  12. Rotciv

    QMS/DMS for an IT company

    Rotciv, Jan 28, 2020
    Replies:
    2
    Views:
    548
    Rotciv
    Jan 28, 2020
  13. Airwolf

    CFU count for DI water sample

    Airwolf, Sep 20, 2019
    Replies:
    2
    Views:
    800
    Sam Lazzara
    Oct 4, 2019
  14. Renaz

    PFMEA in low volume medical device manufacturing

    Renaz, Oct 20, 2018
    Replies:
    2
    Views:
    926
    John C. Abnet
    Oct 22, 2018
  15. ChuckD

    Assigning Serial number at final QC check

    ChuckD, Sep 1, 2017
    Replies:
    2
    Views:
    879
    indicator
    Sep 7, 2017
  16. MonteS

    Must Medical Device Subcomponent Manufacturers Perform IQs and OQs on Existing Equipment?

    MonteS, Sep 27, 2016
    Replies:
    2
    Views:
    954
    Candi1024
    Oct 11, 2016
  17. fialor

    Country of Origin or "Made In" Tags

    fialor, Sep 14, 2016
    Replies:
    2
    Views:
    874
    RoxaneB
    Sep 14, 2016
  18. pcmc47

    Removing Non Value Added Inspection

    pcmc47, Jan 29, 2016
    Replies:
    2
    Views:
    1,044
    Bev D
    Jan 29, 2016
  19. S. Desai

    ISO 13485 - New Facility Question

    S. Desai, Jan 27, 2016
    Replies:
    2
    Views:
    1,051
    S. Desai
    Jan 28, 2016
  20. flyonthewall

    CER Cleaning

    flyonthewall, Apr 24, 2024 at 6:19 PM
    Replies:
    1
    Views:
    64
    Andy Nichols
    Apr 24, 2024 at 8:42 PM
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