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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. Steve Kent

    Quality Agreement

    Steve Kent, Mar 2, 2016
    Replies:
    3
    Views:
    1,475
    Marcelo Antunes
    Mar 4, 2016
  2. Jantani1275

    Quality performing manufacturing

    Jantani1275, Apr 18, 2017
    Replies:
    1
    Views:
    677
    yodon
    Apr 18, 2017
  3. Diane Hunt

    Question on One Sentence in 7.1 of ISO 13485:2016

    Diane Hunt, Aug 28, 2018
    Replies:
    4
    Views:
    1,438
    Diane Hunt
    Aug 29, 2018
  4. Lindy

    Real Registrar?

    Lindy, Apr 16, 2018
    Replies:
    4
    Views:
    1,029
    Andy Nichols
    Apr 16, 2018
  5. laden

    Record Management (paper-based document system)

    laden, Apr 21, 2020
    Replies:
    9
    Views:
    1,026
    Mike S.
    Apr 29, 2020
  6. pcmc47

    Removing Non Value Added Inspection

    pcmc47, Jan 29, 2016
    Replies:
    2
    Views:
    1,047
    Bev D
    Jan 29, 2016
  7. Kymberly

    Review of quality records

    Kymberly, May 2, 2020
    Replies:
    2
    Views:
    663
    Andy Nichols
    May 3, 2020
  8. QA Bee

    Risk Management Process

    QA Bee, Jan 5, 2016
    Replies:
    4
    Views:
    902
    QA Bee
    Jan 6, 2016
  9. Mohsin Farooqui

    Scoping Validation for Incoming Inspection Tools/Equipment

    Mohsin Farooqui, Nov 16, 2017
    Replies:
    1
    Views:
    1,238
    Vintage Goose
    Nov 17, 2017
  10. Rachel

    Shelf life vs Expiration date

    Rachel, Mar 17, 2016
    Replies:
    7
    Views:
    11,252
    Eric Twiname
    Mar 22, 2016
  11. Crossi89

    Should NCMR or rejection be part of DHR?

    Crossi89, Apr 18, 2024
    Replies:
    0
    Views:
    100
    Crossi89
    Apr 18, 2024
  12. Nikki

    Should we keep ISO 9001:2015 when we go for 13485 certification?

    Nikki, Jan 18, 2016
    Replies:
    8
    Views:
    1,818
    Scott K
    Feb 9, 2016
  13. Udirn1

    Spare parts

    Udirn1, Feb 7, 2018
    Replies:
    1
    Views:
    662
    Vintage Goose
    Feb 15, 2018
  14. Stephen1985

    Sterilisation of Medical Devices

    Stephen1985, Aug 2, 2021
    Replies:
    1
    Views:
    675
    yodon
    Aug 2, 2021
  15. Susan7

    Supply for Medical Device - ISO 13485

    Susan7, Mar 21, 2019
    Replies:
    3
    Views:
    828
    tony s
    Mar 22, 2019
  16. Mike Bodine

    Understanding the difference between ISO 13485 and 21 CFR 820

    Mike Bodine, Jan 25, 2017
    Replies:
    5
    Views:
    2,623
    ValeriaGar
    Nov 3, 2020
  17. Nikki

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

    Nikki, Sep 25, 2018
    Replies:
    4
    Views:
    1,364
    tony s
    Mar 22, 2019
  18. Francesco.l

    USB-IF standard includes also ISO13485

    Francesco.l, Apr 30, 2021
    Replies:
    1
    Views:
    730
    Andy Nichols
    Apr 30, 2021
  19. JCIC49

    Use of Sharepoint for controlling documents

    JCIC49, Nov 27, 2015
    Replies:
    6
    Views:
    2,011
    Claes Gefvenberg
    Dec 1, 2015
  20. Nikki

    Validation during Design & Development

    Nikki, Apr 28, 2016
    Replies:
    1
    Views:
    778
    Ronen E
    Apr 28, 2016
Showing threads 81 to 100 of 105

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