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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. Nash Jan

    LAL Testing Frequency

    Nash Jan, Sep 17, 2015
    Replies:
    4
    Views:
    1,783
    Nash Jan
    Sep 18, 2015
  2. Bahamas

    Looking for a wide Rollator /walker and other recommendations

    Bahamas, Jun 9, 2021
    Replies:
    1
    Views:
    509
    Andy Nichols
    Jun 9, 2021
  3. JakobA

    Looking for test people

    JakobA, Mar 2, 2021
    Replies:
    7
    Views:
    722
    JakobA
    Mar 12, 2021
  4. Garrett deBorst

    Looking to have an internal audit performed

    Garrett deBorst, Dec 1, 2020
    Replies:
    5
    Views:
    559
    Andy Nichols
    Dec 1, 2020
  5. Nikki

    Looking to impress at new job

    Nikki, Aug 25, 2020
    Replies:
    13
    Views:
    1,690
    Andy Nichols
    Oct 15, 2020
  6. Lindy

    MDSAP Registrar

    Lindy, Jan 18, 2019
    Replies:
    4
    Views:
    948
    Kymberly
    May 2, 2020
  7. John C. Abnet

    Medical device Non-conformance based on ISO 14971 ?

    John C. Abnet, Nov 30, 2021
    Replies:
    5
    Views:
    768
    John C. Abnet
    Dec 1, 2021
  8. Eloisa Hufana

    Mobile Scooters Classification

    Eloisa Hufana, Feb 13, 2024
    Replies:
    2
    Views:
    418
    Eloisa Hufana
    Feb 19, 2024
  9. MonteS

    Must Medical Device Subcomponent Manufacturers Perform IQs and OQs on Existing Equipment?

    MonteS, Sep 27, 2016
    Replies:
    2
    Views:
    955
    Candi1024
    Oct 11, 2016
  10. Jonathan Wilkie

    NB's auditing practice called into question...

    Jonathan Wilkie, Jan 19, 2016
    Replies:
    4
    Views:
    1,625
    Jonathan Wilkie
    Jan 20, 2016
  11. ankit

    Need this standard-Help

    ankit, Oct 11, 2017
    Replies:
    1
    Views:
    747
    Atul Khandekar
    Oct 11, 2017
  12. DarisQ

    New chapter 4.2.3 Medical Device file

    DarisQ, May 9, 2016
    Replies:
    4
    Views:
    4,854
    TerryMc
    Jul 15, 2016
  13. Lindy

    On-site Supplier Audit Checklist

    Lindy, Jan 31, 2018
    Replies:
    7
    Views:
    3,359
    RoxaneB
    Apr 9, 2018
  14. Renaz

    PFMEA in low volume medical device manufacturing

    Renaz, Oct 20, 2018
    Replies:
    2
    Views:
    927
    John C. Abnet
    Oct 22, 2018
  15. Jimbo11

    Preparation For Upcoming External Audit 13485

    Jimbo11, Sep 3, 2018
    Replies:
    3
    Views:
    940
    Andy Nichols
    Sep 4, 2018
  16. Lindy

    Procedure Deviations

    Lindy, Feb 1, 2019
    Replies:
    3
    Views:
    735
    Andy Nichols
    Feb 1, 2019
  17. RICHARD GALLAGHER

    Product Design Project Checklist?

    RICHARD GALLAGHER, Dec 11, 2015
    Replies:
    10
    Views:
    2,979
    QAengineer13
    Feb 3, 2016
  18. K Muela

    Purchasing data review requirements

    K Muela, Apr 26, 2016
    Replies:
    4
    Views:
    1,387
    matkins151
    Apr 28, 2016
  19. Rotciv

    QMS/DMS for an IT company

    Rotciv, Jan 28, 2020
    Replies:
    2
    Views:
    551
    Rotciv
    Jan 28, 2020
  20. Abdullah

    Qualification of HVAC system

    Abdullah, Dec 27, 2015
    Replies:
    9
    Views:
    1,395
    Jennifer Kirley
    Dec 29, 2015
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