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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. duff999

    Equipment validations

    duff999, Sep 26, 2019
    Replies:
    2
    Views:
    738
    duff999
    Aug 26, 2020
  2. Mandy

    How often to calibrate an analytical balance

    Mandy, Dec 6, 2015
    Replies:
    1
    Views:
    739
    Eric Twiname
    Dec 7, 2015
  3. Lindy

    Procedure Deviations

    Lindy, Feb 1, 2019
    Replies:
    3
    Views:
    740
    Andy Nichols
    Feb 1, 2019
  4. ASFAR _to_ISOFDA

    FDA & ISO 13485 Customer Supplied Material

    ASFAR _to_ISOFDA, Jun 8, 2017
    Replies:
    1
    Views:
    742
    yodon
    Jun 9, 2017
  5. ankit

    Need this standard-Help

    ankit, Oct 11, 2017
    Replies:
    1
    Views:
    750
    Atul Khandekar
    Oct 11, 2017
  6. Nikki

    Can I Exclude These 13485 requirements?

    Nikki, Jan 28, 2016
    Replies:
    1
    Views:
    769
    Ronen E
    Jan 28, 2016
  7. Lindy

    ISO 13485:2016 Procedures in China

    Lindy, Nov 4, 2019
    Replies:
    1
    Views:
    773
    Golfman25
    Nov 4, 2019
  8. Jeremy B Maher

    ISO13485 Clause 8.3 and Sub-Clause 8.3.2 and 8.3.3

    Jeremy B Maher, Oct 26, 2023
    Replies:
    4
    Views:
    773
    Andy Nichols
    Nov 1, 2023
  9. John C. Abnet

    Medical device Non-conformance based on ISO 14971 ?

    John C. Abnet, Nov 30, 2021
    Replies:
    5
    Views:
    781
    John C. Abnet
    Dec 1, 2021
  10. Nikki

    Validation during Design & Development

    Nikki, Apr 28, 2016
    Replies:
    1
    Views:
    782
    Ronen E
    Apr 28, 2016
  11. Airwolf

    CFU count for DI water sample

    Airwolf, Sep 20, 2019
    Replies:
    2
    Views:
    811
    Sam Lazzara
    Oct 4, 2019
  12. Susan7

    Supply for Medical Device - ISO 13485

    Susan7, Mar 21, 2019
    Replies:
    3
    Views:
    833
    tony s
    Mar 22, 2019
  13. Mariah

    "Life Time of a Medical Device"

    Mariah, Dec 9, 2019
    Replies:
    0
    Views:
    868
    Mariah
    Dec 9, 2019
  14. fialor

    Country of Origin or "Made In" Tags

    fialor, Sep 14, 2016
    Replies:
    2
    Views:
    878
    RoxaneB
    Sep 14, 2016
  15. Louise

    Critical Supplier Agreement

    Louise, Feb 1, 2016
    Replies:
    0
    Views:
    886
    Louise
    Feb 1, 2016
  16. ChuckD

    Assigning Serial number at final QC check

    ChuckD, Sep 1, 2017
    Replies:
    2
    Views:
    892
    indicator
    Sep 7, 2017
  17. QA Bee

    Risk Management Process

    QA Bee, Jan 5, 2016
    Replies:
    4
    Views:
    907
    QA Bee
    Jan 6, 2016
  18. HeathW

    Is validation of training tools required?

    HeathW, Mar 26, 2021
    Replies:
    5
    Views:
    916
    HeathW
    Apr 1, 2021
  19. Renaz

    PFMEA in low volume medical device manufacturing

    Renaz, Oct 20, 2018
    Replies:
    2
    Views:
    932
    John C. Abnet
    Oct 22, 2018
  20. Jimbo11

    Preparation For Upcoming External Audit 13485

    Jimbo11, Sep 3, 2018
    Replies:
    3
    Views:
    941
    Andy Nichols
    Sep 4, 2018
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