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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. Kamil

    Clean Room Environments Specifications

    Kamil, Feb 22, 2021 at 7:44 AM
    Replies:
    0
    Views:
    32
    Kamil
    Feb 22, 2021 at 7:44 AM
  2. Stephen Lennon

    ISO 13485:2016 clause 8.2.4

    Stephen Lennon, Feb 16, 2021
    Replies:
    3
    Views:
    98
    Andy Nichols
    Feb 16, 2021
  3. neil300n

    Job opportunity - ISO 13485 Quality Compliance Officer, London

    neil300n, Dec 31, 2020
    Replies:
    0
    Views:
    255
    neil300n
    Dec 31, 2020
  4. ValeriaGar

    What do you think about Remote Audit during COVID 19?

    ValeriaGar, Dec 22, 2020
    Replies:
    6
    Views:
    188
    Jennifer Kirley
    Dec 31, 2020
  5. John Thacher

    Doing Less Change Orders by Allowing Part Interchangeability

    John Thacher, Dec 16, 2020
    Replies:
    1
    Views:
    107
    yodon
    Dec 18, 2020
  6. Garrett deBorst

    Looking to have an internal audit performed

    Garrett deBorst, Dec 1, 2020
    Replies:
    5
    Views:
    163
    Andy Nichols
    Dec 1, 2020
  7. Nikki

    How much work to get to 13485 from ISO 9001:2015?

    Nikki, Dec 4, 2015 ... 2
    Replies:
    23
    Views:
    1,617
    John C. Abnet
    Nov 5, 2020
  8. Mike Bodine

    Understanding the difference between ISO 13485 and 21 CFR 820

    Mike Bodine, Jan 25, 2017
    Replies:
    5
    Views:
    1,567
    ValeriaGar
    Nov 3, 2020
  9. KD Shah

    How to get ISO 13485

    KD Shah, Dec 6, 2019
    Replies:
    4
    Views:
    445
    ValeriaGar
    Nov 3, 2020
  10. Nikki

    Looking to impress at new job

    Nikki, Aug 25, 2020
    Replies:
    13
    Views:
    516
    Andy Nichols
    Oct 15, 2020
  11. Nikki

    What is "Deduction of Points"?

    Nikki, Oct 14, 2020
    Replies:
    0
    Views:
    85
    Nikki
    Oct 14, 2020
  12. Luca Ercolani

    Adobe Sign as digital signature tool

    Luca Ercolani, Jun 8, 2020
    Replies:
    2
    Views:
    638
    Steven Severt
    Sep 19, 2020
  13. duff999

    Equipment validations

    duff999, Sep 26, 2019
    Replies:
    2
    Views:
    355
    duff999
    Aug 26, 2020
  14. AdaTW22

    Is a software platform a medical device???

    AdaTW22, Mar 9, 2020
    Replies:
    2
    Views:
    715
    Maryna
    Jun 9, 2020
  15. Kymberly

    Review of quality records

    Kymberly, May 2, 2020
    Replies:
    2
    Views:
    328
    Andy Nichols
    May 3, 2020
  16. Lindy

    MDSAP Registrar

    Lindy, Jan 18, 2019
    Replies:
    4
    Views:
    436
    Kymberly
    May 2, 2020
  17. laden

    Record Management (paper-based document system)

    laden, Apr 21, 2020
    Replies:
    9
    Views:
    359
    Mike S.
    Apr 29, 2020
  18. MIGUEL LUNA

    Inspection KPI's, Who Has Examles and What is Measured?

    MIGUEL LUNA, Jan 28, 2020
    Replies:
    9
    Views:
    548
    MIGUEL LUNA
    Jan 30, 2020
  19. Rotciv

    QMS/DMS for an IT company

    Rotciv, Jan 28, 2020
    Replies:
    2
    Views:
    224
    Rotciv
    Jan 28, 2020
  20. Mariah

    "Life Time of a Medical Device"

    Mariah, Dec 9, 2019
    Replies:
    0
    Views:
    443
    Mariah
    Dec 9, 2019
Showing threads 1 to 20 of 88

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