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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. Mariah

    "Life Time of a Medical Device"

    Mariah, Dec 9, 2019
    Replies:
    0
    Views:
    243
    Mariah
    Dec 9, 2019
  2. KD Shah

    How to get ISO 13485

    KD Shah, Dec 6, 2019
    Replies:
    2
    Views:
    77
    Andy Nichols
    Dec 7, 2019
  3. Lindy

    ISO 13485:2016 Procedures in China

    Lindy, Nov 4, 2019
    Replies:
    1
    Views:
    170
    Golfman25
    Nov 4, 2019
  4. Airwolf

    CFU count for DI water sample

    Airwolf, Sep 20, 2019
    Replies:
    2
    Views:
    256
    Sam Lazzara
    Oct 4, 2019
  5. duff999

    Equipment validations

    duff999, Sep 26, 2019
    Replies:
    0
    Views:
    119
    duff999
    Sep 26, 2019
  6. Lindy

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

    Lindy, Apr 17, 2019
    Replies:
    3
    Views:
    693
    Andy Nichols
    Apr 26, 2019
  7. Nikki

    13485:2016 Internal Auditing Online Course?

    Nikki, Mar 8, 2019
    Replies:
    7
    Views:
    520
    Chaitany Thaker
    Apr 15, 2019
  8. Susan7

    Supply for Medical Device - ISO 13485

    Susan7, Mar 21, 2019
    Replies:
    3
    Views:
    313
    tony s
    Mar 22, 2019
  9. Nikki

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

    Nikki, Sep 25, 2018
    Replies:
    5
    Views:
    690
    tony s
    Mar 22, 2019
  10. Lindy

    Procedure Deviations

    Lindy, Feb 1, 2019
    Replies:
    3
    Views:
    212
    Andy Nichols
    Feb 1, 2019
  11. Lindy

    MDSAP Registrar

    Lindy, Jan 18, 2019
    Replies:
    3
    Views:
    241
    Andy Nichols
    Jan 21, 2019
  12. Neha_Mate

    What is the Medical Device Classification?

    Neha_Mate, Jan 14, 2019
    Replies:
    0
    Views:
    197
    Neha_Mate
    Jan 14, 2019
  13. Greig

    ISO13485 - The correct standard for pharmaceutical packaging?

    Greig, Jul 3, 2018
    Replies:
    7
    Views:
    770
    Greig
    Nov 28, 2018
  14. Renaz

    PFMEA in low volume medical device manufacturing

    Renaz, Oct 20, 2018
    Replies:
    2
    Views:
    322
    John C. Abnet
    Oct 22, 2018
  15. Karly Chester Etzel

    Design and Development Plan

    Karly Chester Etzel, Sep 25, 2018
    Replies:
    4
    Views:
    491
    Karly Chester Etzel
    Oct 9, 2018
  16. Jimbo11

    Preparation For Upcoming External Audit 13485

    Jimbo11, Sep 3, 2018
    Replies:
    3
    Views:
    392
    Andy Nichols
    Sep 4, 2018
  17. Diane Hunt

    Question on One Sentence in 7.1 of ISO 13485:2016

    Diane Hunt, Aug 28, 2018
    Replies:
    4
    Views:
    445
    Diane Hunt
    Aug 29, 2018
  18. Nikki

    GDP - Having to give a reason to use N/A?

    Nikki, Jun 18, 2018
    Replies:
    7
    Views:
    549
    John C. Abnet
    Jun 19, 2018
  19. Lindy

    Real Registrar?

    Lindy, Apr 16, 2018
    Replies:
    4
    Views:
    541
    Andy Nichols
    Apr 16, 2018
  20. Lindy

    On-site Supplier Audit Checklist

    Lindy, Jan 31, 2018
    Replies:
    7
    Views:
    1,369
    RoxaneB
    Apr 9, 2018
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