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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:
    4
    Views:
    3,160
    felicebehaviour
    Sep 25, 2024
  2. Mabel Ng

    Reviewer and Approver level

    Mabel Ng, Sep 5, 2024
    Replies:
    2
    Views:
    477
    yodon
    Sep 5, 2024
  3. Agnes N.

    7.5.6 Validation of processes for production and service provision

    Agnes N., Apr 27, 2024
    Replies:
    2
    Views:
    1,422
    yodon
    Apr 30, 2024
  4. flyonthewall

    CER Cleaning

    flyonthewall, Apr 24, 2024
    Replies:
    1
    Views:
    516
    Andy Nichols
    Apr 24, 2024
  5. Crossi89

    Should NCMR or rejection be part of DHR?

    Crossi89, Apr 18, 2024
    Replies:
    0
    Views:
    421
    Crossi89
    Apr 18, 2024
  6. Eloisa Hufana

    Mobile Scooters Classification

    Eloisa Hufana, Feb 13, 2024
    Replies:
    2
    Views:
    796
    Eloisa Hufana
    Feb 19, 2024
  7. Jeremy B Maher

    ISO13485 Clause 8.3 and Sub-Clause 8.3.2 and 8.3.3

    Jeremy B Maher, Oct 26, 2023
    Replies:
    4
    Views:
    1,743
    Andy Nichols
    Nov 1, 2023
  8. Kishnu Vaarma ROSS

    ISO 13485

    Kishnu Vaarma ROSS, Nov 3, 2022
    Replies:
    3
    Views:
    2,253
    Kishnu Vaarma ROSS
    Nov 14, 2022
  9. yzl1018

    Is there any Brazilian biosafety standard or regulation?

    yzl1018, Dec 18, 2021
    Replies:
    0
    Views:
    2,108
    yzl1018
    Dec 18, 2021
  10. John C. Abnet

    Medical device Non-conformance based on ISO 14971 ?

    John C. Abnet, Nov 30, 2021
    Replies:
    5
    Views:
    1,187
    John C. Abnet
    Dec 1, 2021
  11. Malius

    Infallibility of QA department?

    Malius, Nov 18, 2021
    Replies:
    10
    Views:
    1,788
    Jennifer Kirley
    Nov 23, 2021
  12. Jimqa

    Best practice in tracking changes in Records

    Jimqa, Nov 15, 2021
    Replies:
    6
    Views:
    1,039
    Andy Nichols
    Nov 18, 2021
  13. TKOMaine

    Design company not ISO13485 using a Manufacturing company that is ISO13485.

    TKOMaine, Nov 9, 2021
    Replies:
    7
    Views:
    1,245
    Andy Nichols
    Nov 10, 2021
  14. Stephen1985

    Sterilisation of Medical Devices

    Stephen1985, Aug 2, 2021
    Replies:
    1
    Views:
    930
    yodon
    Aug 2, 2021
  15. Kamil

    Clean Room Environments Specifications

    Kamil, Feb 22, 2021
    Replies:
    1
    Views:
    1,048
    Mary
    Jun 22, 2021
  16. Bahamas

    Looking for a wide Rollator /walker and other recommendations

    Bahamas, Jun 9, 2021
    Replies:
    1
    Views:
    931
    Andy Nichols
    Jun 9, 2021
  17. Francesco.l

    USB-IF standard includes also ISO13485

    Francesco.l, Apr 30, 2021
    Replies:
    1
    Views:
    1,042
    Andy Nichols
    Apr 30, 2021
  18. HeathW

    Is validation of training tools required?

    HeathW, Mar 26, 2021
    Replies:
    5
    Views:
    1,271
    HeathW
    Apr 1, 2021
  19. JakobA

    Looking for test people

    JakobA, Mar 2, 2021
    Replies:
    7
    Views:
    994
    JakobA
    Mar 12, 2021
  20. Stephen Lennon

    ISO 13485:2016 clause 8.2.4

    Stephen Lennon, Feb 16, 2021
    Replies:
    3
    Views:
    3,100
    Andy Nichols
    Feb 16, 2021
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