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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. Ana Silva

    ISO13485: Marketing materials and design files

    Ana Silva, Aug 24, 2021
    Replies:
    3
    Views:
    224
    Ana Silva
    Aug 24, 2021
  2. Stephen1985

    Sterilisation of Medical Devices

    Stephen1985, Aug 2, 2021
    Replies:
    1
    Views:
    161
    yodon
    Aug 2, 2021
  3. Kamil

    Clean Room Environments Specifications

    Kamil, Feb 22, 2021
    Replies:
    1
    Views:
    374
    Mary
    Jun 22, 2021
  4. Bahamas

    Looking for a wide Rollator /walker and other recommendations

    Bahamas, Jun 9, 2021
    Replies:
    1
    Views:
    184
    Andy Nichols
    Jun 9, 2021
  5. Francesco.l

    USB-IF standard includes also ISO13485

    Francesco.l, Apr 30, 2021
    Replies:
    1
    Views:
    277
    Andy Nichols
    Apr 30, 2021
  6. HeathW

    Is validation of training tools required?

    HeathW, Mar 26, 2021
    Replies:
    5
    Views:
    353
    HeathW
    Apr 1, 2021
  7. JakobA

    Looking for test people

    JakobA, Mar 2, 2021
    Replies:
    7
    Views:
    358
    JakobA
    Mar 12, 2021
  8. Stephen Lennon

    ISO 13485:2016 clause 8.2.4

    Stephen Lennon, Feb 16, 2021
    Replies:
    3
    Views:
    310
    Andy Nichols
    Feb 16, 2021
  9. neil300n

    Job opportunity - ISO 13485 Quality Compliance Officer, London

    neil300n, Dec 31, 2020
    Replies:
    0
    Views:
    370
    neil300n
    Dec 31, 2020
  10. ValeriaGar

    What do you think about Remote Audit during COVID 19?

    ValeriaGar, Dec 22, 2020
    Replies:
    6
    Views:
    483
    Jennifer Kirley
    Dec 31, 2020
  11. John Thacher

    Doing Less Change Orders by Allowing Part Interchangeability

    John Thacher, Dec 16, 2020
    Replies:
    1
    Views:
    188
    yodon
    Dec 18, 2020
  12. Garrett deBorst

    Looking to have an internal audit performed

    Garrett deBorst, Dec 1, 2020
    Replies:
    5
    Views:
    266
    Andy Nichols
    Dec 1, 2020
  13. Nikki

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

    Nikki, Dec 4, 2015 ... 2
    Replies:
    23
    Views:
    1,927
    John C. Abnet
    Nov 5, 2020
  14. Mike Bodine

    Understanding the difference between ISO 13485 and 21 CFR 820

    Mike Bodine, Jan 25, 2017
    Replies:
    5
    Views:
    1,824
    ValeriaGar
    Nov 3, 2020
  15. KD Shah

    How to get ISO 13485

    KD Shah, Dec 6, 2019
    Replies:
    4
    Views:
    636
    ValeriaGar
    Nov 3, 2020
  16. Nikki

    Looking to impress at new job

    Nikki, Aug 25, 2020
    Replies:
    13
    Views:
    734
    Andy Nichols
    Oct 15, 2020
  17. Nikki

    What is "Deduction of Points"?

    Nikki, Oct 14, 2020
    Replies:
    0
    Views:
    240
    Nikki
    Oct 14, 2020
  18. Luca Ercolani

    Adobe Sign as digital signature tool

    Luca Ercolani, Jun 8, 2020
    Replies:
    2
    Views:
    870
    Steven Severt
    Sep 19, 2020
  19. duff999

    Equipment validations

    duff999, Sep 26, 2019
    Replies:
    2
    Views:
    467
    duff999
    Aug 26, 2020
  20. AdaTW22

    Is a software platform a medical device???

    AdaTW22, Mar 9, 2020
    Replies:
    2
    Views:
    1,096
    Maryna
    Jun 9, 2020
Showing threads 1 to 20 of 94

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