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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. Crossi89

    Should NCMR or rejection be part of DHR?

    Crossi89, Apr 18, 2024
    Replies:
    0
    Views:
    106
    Crossi89
    Apr 18, 2024
  2. yzl1018

    Is there any Brazilian biosafety standard or regulation?

    yzl1018, Dec 18, 2021
    Replies:
    0
    Views:
    1,841
    yzl1018
    Dec 18, 2021
  3. neil300n

    Job opportunity - ISO 13485 Quality Compliance Officer, London

    neil300n, Dec 31, 2020
    Replies:
    0
    Views:
    697
    neil300n
    Dec 31, 2020
  4. Nikki

    What is "Deduction of Points"?

    Nikki, Oct 14, 2020
    Replies:
    0
    Views:
    449
    Nikki
    Oct 14, 2020
  5. Mariah

    "Life Time of a Medical Device"

    Mariah, Dec 9, 2019
    Replies:
    0
    Views:
    866
    Mariah
    Dec 9, 2019
  6. Neha_Mate

    What is the Medical Device Classification?

    Neha_Mate, Jan 14, 2019
    Replies:
    0
    Views:
    659
    Neha_Mate
    Jan 14, 2019
  7. Louise

    Critical Supplier Agreement

    Louise, Feb 1, 2016
    Replies:
    0
    Views:
    885
    Louise
    Feb 1, 2016
  8. flyonthewall

    CER Cleaning

    flyonthewall, Apr 24, 2024
    Replies:
    1
    Views:
    108
    Andy Nichols
    Apr 24, 2024
  9. Stephen1985

    Sterilisation of Medical Devices

    Stephen1985, Aug 2, 2021
    Replies:
    1
    Views:
    676
    yodon
    Aug 2, 2021
  10. Kamil

    Clean Room Environments Specifications

    Kamil, Feb 22, 2021
    Replies:
    1
    Views:
    735
    Mary
    Jun 22, 2021
  11. Bahamas

    Looking for a wide Rollator /walker and other recommendations

    Bahamas, Jun 9, 2021
    Replies:
    1
    Views:
    511
    Andy Nichols
    Jun 9, 2021
  12. Francesco.l

    USB-IF standard includes also ISO13485

    Francesco.l, Apr 30, 2021
    Replies:
    1
    Views:
    733
    Andy Nichols
    Apr 30, 2021
  13. John Thacher

    Doing Less Change Orders by Allowing Part Interchangeability

    John Thacher, Dec 16, 2020
    Replies:
    1
    Views:
    550
    yodon
    Dec 18, 2020
  14. Lindy

    ISO 13485:2016 Procedures in China

    Lindy, Nov 4, 2019
    Replies:
    1
    Views:
    768
    Golfman25
    Nov 4, 2019
  15. Udirn1

    Spare parts

    Udirn1, Feb 7, 2018
    Replies:
    1
    Views:
    664
    Vintage Goose
    Feb 15, 2018
  16. Mohsin Farooqui

    Scoping Validation for Incoming Inspection Tools/Equipment

    Mohsin Farooqui, Nov 16, 2017
    Replies:
    1
    Views:
    1,241
    Vintage Goose
    Nov 17, 2017
  17. Qualityforum Mainar

    Does 13485:2016 - 7.2.3 Customer Communication include marketing?

    Qualityforum Mainar, Nov 10, 2017
    Replies:
    1
    Views:
    1,359
    yodon
    Nov 15, 2017
  18. ankit

    Need this standard-Help

    ankit, Oct 11, 2017
    Replies:
    1
    Views:
    748
    Atul Khandekar
    Oct 11, 2017
  19. ASFAR _to_ISOFDA

    FDA & ISO 13485 Customer Supplied Material

    ASFAR _to_ISOFDA, Jun 8, 2017
    Replies:
    1
    Views:
    739
    yodon
    Jun 9, 2017
  20. Jantani1275

    Quality performing manufacturing

    Jantani1275, Apr 18, 2017
    Replies:
    1
    Views:
    680
    yodon
    Apr 18, 2017
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