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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 at 8:09 PM
    Replies:
    0
    Views:
    89
    Crossi89
    Apr 18, 2024 at 8:09 PM
  2. yzl1018

    Is there any Brazilian biosafety standard or regulation?

    yzl1018, Dec 18, 2021
    Replies:
    0
    Views:
    1,834
    yzl1018
    Dec 18, 2021
  3. neil300n

    Job opportunity - ISO 13485 Quality Compliance Officer, London

    neil300n, Dec 31, 2020
    Replies:
    0
    Views:
    689
    neil300n
    Dec 31, 2020
  4. Nikki

    What is "Deduction of Points"?

    Nikki, Oct 14, 2020
    Replies:
    0
    Views:
    444
    Nikki
    Oct 14, 2020
  5. Mariah

    "Life Time of a Medical Device"

    Mariah, Dec 9, 2019
    Replies:
    0
    Views:
    862
    Mariah
    Dec 9, 2019
  6. Neha_Mate

    What is the Medical Device Classification?

    Neha_Mate, Jan 14, 2019
    Replies:
    0
    Views:
    648
    Neha_Mate
    Jan 14, 2019
  7. Louise

    Critical Supplier Agreement

    Louise, Feb 1, 2016
    Replies:
    0
    Views:
    883
    Louise
    Feb 1, 2016
  8. Stephen1985

    Sterilisation of Medical Devices

    Stephen1985, Aug 2, 2021
    Replies:
    1
    Views:
    672
    yodon
    Aug 2, 2021
  9. Kamil

    Clean Room Environments Specifications

    Kamil, Feb 22, 2021
    Replies:
    1
    Views:
    730
    Mary
    Jun 22, 2021
  10. Bahamas

    Looking for a wide Rollator /walker and other recommendations

    Bahamas, Jun 9, 2021
    Replies:
    1
    Views:
    506
    Andy Nichols
    Jun 9, 2021
  11. Francesco.l

    USB-IF standard includes also ISO13485

    Francesco.l, Apr 30, 2021
    Replies:
    1
    Views:
    724
    Andy Nichols
    Apr 30, 2021
  12. John Thacher

    Doing Less Change Orders by Allowing Part Interchangeability

    John Thacher, Dec 16, 2020
    Replies:
    1
    Views:
    546
    yodon
    Dec 18, 2020
  13. Lindy

    ISO 13485:2016 Procedures in China

    Lindy, Nov 4, 2019
    Replies:
    1
    Views:
    760
    Golfman25
    Nov 4, 2019
  14. Udirn1

    Spare parts

    Udirn1, Feb 7, 2018
    Replies:
    1
    Views:
    659
    Vintage Goose
    Feb 15, 2018
  15. Mohsin Farooqui

    Scoping Validation for Incoming Inspection Tools/Equipment

    Mohsin Farooqui, Nov 16, 2017
    Replies:
    1
    Views:
    1,235
    Vintage Goose
    Nov 17, 2017
  16. Qualityforum Mainar

    Does 13485:2016 - 7.2.3 Customer Communication include marketing?

    Qualityforum Mainar, Nov 10, 2017
    Replies:
    1
    Views:
    1,337
    yodon
    Nov 15, 2017
  17. ankit

    Need this standard-Help

    ankit, Oct 11, 2017
    Replies:
    1
    Views:
    745
    Atul Khandekar
    Oct 11, 2017
  18. ASFAR _to_ISOFDA

    FDA & ISO 13485 Customer Supplied Material

    ASFAR _to_ISOFDA, Jun 8, 2017
    Replies:
    1
    Views:
    735
    yodon
    Jun 9, 2017
  19. Jantani1275

    Quality performing manufacturing

    Jantani1275, Apr 18, 2017
    Replies:
    1
    Views:
    673
    yodon
    Apr 18, 2017
  20. Jura1752

    ISO 13485 7.4.1 Purchasing Process

    Jura1752, Aug 7, 2016
    Replies:
    1
    Views:
    2,170
    yodon
    Aug 8, 2016
Showing threads 1 to 20 of 103

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