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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. Nikki

    How much work to get to 13485 from ISO 9001:2015?

    Nikki, Dec 4, 2015 ... 2
    Replies:
    23
    Views:
    1,473
    John C. Abnet
    Nov 5, 2020
  2. Mike Bodine

    Understanding the difference between ISO 13485 and 21 CFR 820

    Mike Bodine, Jan 25, 2017
    Replies:
    5
    Views:
    1,459
    ValeriaGar
    Nov 3, 2020
  3. KD Shah

    How to get ISO 13485

    KD Shah, Dec 6, 2019
    Replies:
    4
    Views:
    376
    ValeriaGar
    Nov 3, 2020
  4. Nikki

    Looking to impress at new job

    Nikki, Aug 25, 2020
    Replies:
    13
    Views:
    452
    Andy Nichols
    Oct 15, 2020
  5. Nikki

    What is "Deduction of Points"?

    Nikki, Oct 14, 2020
    Replies:
    0
    Views:
    51
    Nikki
    Oct 14, 2020
  6. Luca Ercolani

    Adobe Sign as digital signature tool

    Luca Ercolani, Jun 8, 2020
    Replies:
    2
    Views:
    548
    Steven Severt
    Sep 19, 2020
  7. duff999

    Equipment validations

    duff999, Sep 26, 2019
    Replies:
    2
    Views:
    318
    duff999
    Aug 26, 2020
  8. AdaTW22

    Is a software platform a medical device???

    AdaTW22, Mar 9, 2020
    Replies:
    2
    Views:
    581
    Maryna
    Jun 9, 2020
  9. Kymberly

    Review of quality records

    Kymberly, May 2, 2020
    Replies:
    2
    Views:
    301
    Andy Nichols
    May 3, 2020
  10. Lindy

    MDSAP Registrar

    Lindy, Jan 18, 2019
    Replies:
    4
    Views:
    395
    Kymberly
    May 2, 2020
  11. laden

    Record Management (paper-based document system)

    laden, Apr 21, 2020
    Replies:
    9
    Views:
    304
    Mike S.
    Apr 29, 2020
  12. MIGUEL LUNA

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

    MIGUEL LUNA, Jan 28, 2020
    Replies:
    9
    Views:
    484
    MIGUEL LUNA
    Jan 30, 2020
  13. Rotciv

    QMS/DMS for an IT company

    Rotciv, Jan 28, 2020
    Replies:
    2
    Views:
    182
    Rotciv
    Jan 28, 2020
  14. Mariah

    "Life Time of a Medical Device"

    Mariah, Dec 9, 2019
    Replies:
    0
    Views:
    405
    Mariah
    Dec 9, 2019
  15. Lindy

    ISO 13485:2016 Procedures in China

    Lindy, Nov 4, 2019
    Replies:
    1
    Views:
    300
    Golfman25
    Nov 4, 2019
  16. Airwolf

    CFU count for DI water sample

    Airwolf, Sep 20, 2019
    Replies:
    2
    Views:
    384
    Sam Lazzara
    Oct 4, 2019
  17. Lindy

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

    Lindy, Apr 17, 2019
    Replies:
    3
    Views:
    826
    Andy Nichols
    Apr 26, 2019
  18. Nikki

    13485:2016 Internal Auditing Online Course?

    Nikki, Mar 8, 2019
    Replies:
    7
    Views:
    882
    Chaitany Thaker
    Apr 15, 2019
  19. Susan7

    Supply for Medical Device - ISO 13485

    Susan7, Mar 21, 2019
    Replies:
    3
    Views:
    458
    tony s
    Mar 22, 2019
  20. Nikki

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

    Nikki, Sep 25, 2018
    Replies:
    5
    Views:
    855
    tony s
    Mar 22, 2019
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