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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. Agnes N.

    7.5.6 Validation of processes for production and service provision

    Agnes N., Apr 27, 2024 at 7:15 PM
    Replies:
    1
    Views:
    73
    Andy Nichols
    Apr 28, 2024 at 3:27 PM
  2. flyonthewall

    CER Cleaning

    flyonthewall, Apr 24, 2024 at 6:19 PM
    Replies:
    1
    Views:
    86
    Andy Nichols
    Apr 24, 2024 at 8:42 PM
  3. Crossi89

    Should NCMR or rejection be part of DHR?

    Crossi89, Apr 18, 2024
    Replies:
    0
    Views:
    97
    Crossi89
    Apr 18, 2024
  4. Eloisa Hufana

    Mobile Scooters Classification

    Eloisa Hufana, Feb 13, 2024
    Replies:
    2
    Views:
    415
    Eloisa Hufana
    Feb 19, 2024
  5. Nikki

    What is "Deduction of Points"?

    Nikki, Oct 14, 2020
    Replies:
    0
    Views:
    447
    Nikki
    Oct 14, 2020
  6. Bahamas

    Looking for a wide Rollator /walker and other recommendations

    Bahamas, Jun 9, 2021
    Replies:
    1
    Views:
    508
    Andy Nichols
    Jun 9, 2021
  7. John Thacher

    Doing Less Change Orders by Allowing Part Interchangeability

    John Thacher, Dec 16, 2020
    Replies:
    1
    Views:
    549
    yodon
    Dec 18, 2020
  8. Rotciv

    QMS/DMS for an IT company

    Rotciv, Jan 28, 2020
    Replies:
    2
    Views:
    550
    Rotciv
    Jan 28, 2020
  9. Jimqa

    Best practice in tracking changes in Records

    Jimqa, Nov 15, 2021
    Replies:
    6
    Views:
    554
    Andy Nichols
    Nov 18, 2021
  10. Garrett deBorst

    Looking to have an internal audit performed

    Garrett deBorst, Dec 1, 2020
    Replies:
    5
    Views:
    557
    Andy Nichols
    Dec 1, 2020
  11. Neha_Mate

    What is the Medical Device Classification?

    Neha_Mate, Jan 14, 2019
    Replies:
    0
    Views:
    654
    Neha_Mate
    Jan 14, 2019
  12. Udirn1

    Spare parts

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

    Review of quality records

    Kymberly, May 2, 2020
    Replies:
    2
    Views:
    663
    Andy Nichols
    May 3, 2020
  14. Stephen1985

    Sterilisation of Medical Devices

    Stephen1985, Aug 2, 2021
    Replies:
    1
    Views:
    675
    yodon
    Aug 2, 2021
  15. Jantani1275

    Quality performing manufacturing

    Jantani1275, Apr 18, 2017
    Replies:
    1
    Views:
    676
    yodon
    Apr 18, 2017
  16. neil300n

    Job opportunity - ISO 13485 Quality Compliance Officer, London

    neil300n, Dec 31, 2020
    Replies:
    0
    Views:
    694
    neil300n
    Dec 31, 2020
  17. TKOMaine

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

    TKOMaine, Nov 9, 2021
    Replies:
    7
    Views:
    717
    Andy Nichols
    Nov 10, 2021
  18. JakobA

    Looking for test people

    JakobA, Mar 2, 2021
    Replies:
    7
    Views:
    722
    JakobA
    Mar 12, 2021
  19. Francesco.l

    USB-IF standard includes also ISO13485

    Francesco.l, Apr 30, 2021
    Replies:
    1
    Views:
    730
    Andy Nichols
    Apr 30, 2021
  20. Kamil

    Clean Room Environments Specifications

    Kamil, Feb 22, 2021
    Replies:
    1
    Views:
    733
    Mary
    Jun 22, 2021
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