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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. Karly Chester Etzel

    Design and Development Plan

    Karly Chester Etzel, Sep 25, 2018
    Replies:
    4
    Views:
    1,390
    Karly Chester Etzel
    Oct 9, 2018
  2. Nikki

    Updating QM to 13485:2016 - We do not make medical devices

    Nikki, Sep 25, 2018
    Replies:
    4
    Views:
    1,367
    tony s
    Mar 22, 2019
  3. Renaz

    PFMEA in low volume medical device manufacturing

    Renaz, Oct 20, 2018
    Replies:
    2
    Views:
    928
    John C. Abnet
    Oct 22, 2018
  4. Neha_Mate

    What is the Medical Device Classification?

    Neha_Mate, Jan 14, 2019
    Replies:
    0
    Views:
    660
    Neha_Mate
    Jan 14, 2019
  5. Lindy

    MDSAP Registrar

    Lindy, Jan 18, 2019
    Replies:
    4
    Views:
    954
    Kymberly
    May 2, 2020
  6. Lindy

    Procedure Deviations

    Lindy, Feb 1, 2019
    Replies:
    3
    Views:
    738
    Andy Nichols
    Feb 1, 2019
  7. Nikki

    13485:2016 Internal Auditing Online Course?

    Nikki, Mar 8, 2019
    Replies:
    7
    Views:
    1,623
    Chaitany Thaker
    Apr 15, 2019
  8. Susan7

    Supply for Medical Device - ISO 13485

    Susan7, Mar 21, 2019
    Replies:
    3
    Views:
    831
    tony s
    Mar 22, 2019
  9. Lindy

    3rd Party Supplier Audit in China: ISO 13485 & 21 CFR 820

    Lindy, Apr 17, 2019
    Replies:
    3
    Views:
    1,421
    Andy Nichols
    Apr 26, 2019
  10. Airwolf

    CFU count for DI water sample

    Airwolf, Sep 20, 2019
    Replies:
    2
    Views:
    807
    Sam Lazzara
    Oct 4, 2019
  11. duff999

    Equipment validations

    duff999, Sep 26, 2019
    Replies:
    2
    Views:
    737
    duff999
    Aug 26, 2020
  12. Lindy

    ISO 13485:2016 Procedures in China

    Lindy, Nov 4, 2019
    Replies:
    1
    Views:
    768
    Golfman25
    Nov 4, 2019
  13. KD Shah

    How to get ISO 13485

    KD Shah, Dec 6, 2019
    Replies:
    4
    Views:
    1,029
    ValeriaGar
    Nov 3, 2020
  14. Mariah

    "Life Time of a Medical Device"

    Mariah, Dec 9, 2019
    Replies:
    0
    Views:
    867
    Mariah
    Dec 9, 2019
  15. MIGUEL LUNA

    Inspection KPI's, Who Has Examles and What is Measured?

    MIGUEL LUNA, Jan 28, 2020
    Replies:
    9
    Views:
    2,832
    MIGUEL LUNA
    Jan 30, 2020
  16. Rotciv

    QMS/DMS for an IT company

    Rotciv, Jan 28, 2020
    Replies:
    2
    Views:
    554
    Rotciv
    Jan 28, 2020
  17. AdaTW22

    Is a software platform a medical device???

    AdaTW22, Mar 9, 2020
    Replies:
    2
    Views:
    2,605
    Maryna
    Jun 9, 2020
  18. laden

    Record Management (paper-based document system)

    laden, Apr 21, 2020
    Replies:
    9
    Views:
    1,033
    Mike S.
    Apr 29, 2020
  19. Kymberly

    Review of quality records

    Kymberly, May 2, 2020
    Replies:
    2
    Views:
    664
    Andy Nichols
    May 3, 2020
  20. Luca Ercolani

    Adobe Sign as digital signature tool

    Luca Ercolani, Jun 8, 2020
    Replies:
    2
    Views:
    1,578
    Steven Severt
    Sep 19, 2020
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