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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. MonteS

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

    MonteS, Sep 27, 2016
    Replies:
    2
    Views:
    959
    Candi1024
    Oct 11, 2016
  2. Lindy

    MDSAP Registrar

    Lindy, Jan 18, 2019
    Replies:
    4
    Views:
    960
    Kymberly
    May 2, 2020
  3. QVarus

    Connecting Complaints and Risk Analysis

    QVarus, Aug 11, 2015
    Replies:
    3
    Views:
    1,014
    OrangeIsEnergy
    Aug 24, 2015
  4. Rahul

    FDA registration and ISO 13485 recertification

    Rahul, Jan 5, 2016
    Replies:
    4
    Views:
    1,033
    Jim Hagenbaugh
    Jan 8, 2016
  5. KD Shah

    How to get ISO 13485

    KD Shah, Dec 6, 2019
    Replies:
    4
    Views:
    1,035
    ValeriaGar
    Nov 3, 2020
  6. laden

    Record Management (paper-based document system)

    laden, Apr 21, 2020
    Replies:
    9
    Views:
    1,041
    Mike S.
    Apr 29, 2020
  7. Lindy

    Real Registrar?

    Lindy, Apr 16, 2018
    Replies:
    4
    Views:
    1,044
    Andy Nichols
    Apr 16, 2018
  8. dr1vn

    Intentional reprocessing of a single use device

    dr1vn, Mar 18, 2016
    Replies:
    5
    Views:
    1,046
    Ronen E
    Mar 29, 2016
  9. S. Desai

    ISO 13485 - New Facility Question

    S. Desai, Jan 27, 2016
    Replies:
    2
    Views:
    1,058
    S. Desai
    Jan 28, 2016
  10. pcmc47

    Removing Non Value Added Inspection

    pcmc47, Jan 29, 2016
    Replies:
    2
    Views:
    1,058
    Bev D
    Jan 29, 2016
  11. karenlin

    Every change required communication?

    karenlin, Apr 8, 2016
    Replies:
    3
    Views:
    1,098
    Jose Ramon Salazar
    Jun 20, 2017
  12. Nomi P

    Equipment SOPs

    Nomi P, Jan 28, 2016
    Replies:
    1
    Views:
    1,113
    yodon
    Jan 29, 2016
  13. Malius

    Infallibility of QA department?

    Malius, Nov 18, 2021
    Replies:
    10
    Views:
    1,228
    Jennifer Kirley
    Nov 23, 2021
  14. Dave L.

    ISO 13485/21 CFR 820 Awareness/Orientation

    Dave L., Sep 1, 2015
    Replies:
    4
    Views:
    1,229
    Dave L.
    Sep 1, 2015
  15. Mohsin Farooqui

    Scoping Validation for Incoming Inspection Tools/Equipment

    Mohsin Farooqui, Nov 16, 2017
    Replies:
    1
    Views:
    1,248
    Vintage Goose
    Nov 17, 2017
  16. QA Bee

    ISO 13485 Pre-Assessment

    QA Bee, Feb 11, 2016
    Replies:
    4
    Views:
    1,274
    QA Bee
    Feb 11, 2016
  17. James Elwood

    13485 and Signed Documents

    James Elwood, Apr 25, 2017
    Replies:
    4
    Views:
    1,280
    Quality Manager Liz
    Nov 24, 2017
  18. ValeriaGar

    What do you think about Remote Audit during COVID 19?

    ValeriaGar, Dec 22, 2020
    Replies:
    6
    Views:
    1,336
    Jennifer Kirley
    Dec 31, 2020
  19. Ana Silva

    ISO13485: Marketing materials and design files

    Ana Silva, Aug 24, 2021
    Replies:
    3
    Views:
    1,338
    Ana Silva
    Aug 24, 2021
  20. PoojaN

    ISO 13485 vs CFR 820

    PoojaN, May 26, 2016
    Replies:
    4
    Views:
    1,341
    Marc Smith
    May 27, 2016
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