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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. ankit

    Need this standard-Help

    ankit, Oct 11, 2017
    Replies:
    1
    Views:
    747
    Atul Khandekar
    Oct 11, 2017
  2. ASFAR _to_ISOFDA

    FDA & ISO 13485 Customer Supplied Material

    ASFAR _to_ISOFDA, Jun 8, 2017
    Replies:
    1
    Views:
    738
    yodon
    Jun 9, 2017
  3. duff999

    Equipment validations

    duff999, Sep 26, 2019
    Replies:
    2
    Views:
    735
    duff999
    Aug 26, 2020
  4. Lindy

    Procedure Deviations

    Lindy, Feb 1, 2019
    Replies:
    3
    Views:
    735
    Andy Nichols
    Feb 1, 2019
  5. Mandy

    How often to calibrate an analytical balance

    Mandy, Dec 6, 2015
    Replies:
    1
    Views:
    734
    Eric Twiname
    Dec 7, 2015
  6. Kamil

    Clean Room Environments Specifications

    Kamil, Feb 22, 2021
    Replies:
    1
    Views:
    733
    Mary
    Jun 22, 2021
  7. Francesco.l

    USB-IF standard includes also ISO13485

    Francesco.l, Apr 30, 2021
    Replies:
    1
    Views:
    730
    Andy Nichols
    Apr 30, 2021
  8. JakobA

    Looking for test people

    JakobA, Mar 2, 2021
    Replies:
    7
    Views:
    722
    JakobA
    Mar 12, 2021
  9. TKOMaine

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

    TKOMaine, Nov 9, 2021
    Replies:
    7
    Views:
    719
    Andy Nichols
    Nov 10, 2021
  10. neil300n

    Job opportunity - ISO 13485 Quality Compliance Officer, London

    neil300n, Dec 31, 2020
    Replies:
    0
    Views:
    694
    neil300n
    Dec 31, 2020
  11. Jantani1275

    Quality performing manufacturing

    Jantani1275, Apr 18, 2017
    Replies:
    1
    Views:
    677
    yodon
    Apr 18, 2017
  12. Stephen1985

    Sterilisation of Medical Devices

    Stephen1985, Aug 2, 2021
    Replies:
    1
    Views:
    675
    yodon
    Aug 2, 2021
  13. Kymberly

    Review of quality records

    Kymberly, May 2, 2020
    Replies:
    2
    Views:
    663
    Andy Nichols
    May 3, 2020
  14. Udirn1

    Spare parts

    Udirn1, Feb 7, 2018
    Replies:
    1
    Views:
    662
    Vintage Goose
    Feb 15, 2018
  15. Neha_Mate

    What is the Medical Device Classification?

    Neha_Mate, Jan 14, 2019
    Replies:
    0
    Views:
    655
    Neha_Mate
    Jan 14, 2019
  16. Garrett deBorst

    Looking to have an internal audit performed

    Garrett deBorst, Dec 1, 2020
    Replies:
    5
    Views:
    560
    Andy Nichols
    Dec 1, 2020
  17. Jimqa

    Best practice in tracking changes in Records

    Jimqa, Nov 15, 2021
    Replies:
    6
    Views:
    556
    Andy Nichols
    Nov 18, 2021
  18. Rotciv

    QMS/DMS for an IT company

    Rotciv, Jan 28, 2020
    Replies:
    2
    Views:
    551
    Rotciv
    Jan 28, 2020
  19. John Thacher

    Doing Less Change Orders by Allowing Part Interchangeability

    John Thacher, Dec 16, 2020
    Replies:
    1
    Views:
    549
    yodon
    Dec 18, 2020
  20. Bahamas

    Looking for a wide Rollator /walker and other recommendations

    Bahamas, Jun 9, 2021
    Replies:
    1
    Views:
    509
    Andy Nichols
    Jun 9, 2021
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