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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. Jura1752

    ISO 13485 7.4.1 Purchasing Process

    Jura1752, Aug 7, 2016
    Replies:
    1
    Views:
    2,201
    yodon
    Aug 8, 2016
  2. Nikki

    Validation during Design & Development

    Nikki, Apr 28, 2016
    Replies:
    1
    Views:
    783
    Ronen E
    Apr 28, 2016
  3. Nomi P

    Equipment SOPs

    Nomi P, Jan 28, 2016
    Replies:
    1
    Views:
    1,113
    yodon
    Jan 29, 2016
  4. Nikki

    Can I Exclude These 13485 requirements?

    Nikki, Jan 28, 2016
    Replies:
    1
    Views:
    770
    Ronen E
    Jan 28, 2016
  5. Mandy

    How often to calibrate an analytical balance

    Mandy, Dec 6, 2015
    Replies:
    1
    Views:
    739
    Eric Twiname
    Dec 7, 2015
  6. Agnes N.

    7.5.6 Validation of processes for production and service provision

    Agnes N., Apr 27, 2024
    Replies:
    2
    Views:
    227
    yodon
    Apr 30, 2024
  7. Eloisa Hufana

    Mobile Scooters Classification

    Eloisa Hufana, Feb 13, 2024
    Replies:
    2
    Views:
    438
    Eloisa Hufana
    Feb 19, 2024
  8. Luca Ercolani

    Adobe Sign as digital signature tool

    Luca Ercolani, Jun 8, 2020
    Replies:
    2
    Views:
    1,583
    Steven Severt
    Sep 19, 2020
  9. duff999

    Equipment validations

    duff999, Sep 26, 2019
    Replies:
    2
    Views:
    739
    duff999
    Aug 26, 2020
  10. AdaTW22

    Is a software platform a medical device???

    AdaTW22, Mar 9, 2020
    Replies:
    2
    Views:
    2,625
    Maryna
    Jun 9, 2020
  11. Kymberly

    Review of quality records

    Kymberly, May 2, 2020
    Replies:
    2
    Views:
    665
    Andy Nichols
    May 3, 2020
  12. Rotciv

    QMS/DMS for an IT company

    Rotciv, Jan 28, 2020
    Replies:
    2
    Views:
    559
    Rotciv
    Jan 28, 2020
  13. Airwolf

    CFU count for DI water sample

    Airwolf, Sep 20, 2019
    Replies:
    2
    Views:
    811
    Sam Lazzara
    Oct 4, 2019
  14. Renaz

    PFMEA in low volume medical device manufacturing

    Renaz, Oct 20, 2018
    Replies:
    2
    Views:
    933
    John C. Abnet
    Oct 22, 2018
  15. ChuckD

    Assigning Serial number at final QC check

    ChuckD, Sep 1, 2017
    Replies:
    2
    Views:
    893
    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:
    958
    Candi1024
    Oct 11, 2016
  17. fialor

    Country of Origin or "Made In" Tags

    fialor, Sep 14, 2016
    Replies:
    2
    Views:
    879
    RoxaneB
    Sep 14, 2016
  18. pcmc47

    Removing Non Value Added Inspection

    pcmc47, Jan 29, 2016
    Replies:
    2
    Views:
    1,056
    Bev D
    Jan 29, 2016
  19. S. Desai

    ISO 13485 - New Facility Question

    S. Desai, Jan 27, 2016
    Replies:
    2
    Views:
    1,057
    S. Desai
    Jan 28, 2016
  20. Kishnu Vaarma ROSS

    ISO 13485

    Kishnu Vaarma ROSS, Nov 3, 2022
    Replies:
    3
    Views:
    1,893
    Kishnu Vaarma ROSS
    Nov 14, 2022
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