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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. Nikki

    GDP - Having to give a reason to use N/A?

    Nikki, Jun 18, 2018
    Replies:
    7
    Views:
    2,906
    John C. Abnet
    Jun 19, 2018
  2. Lindy

    On-site Supplier Audit Checklist

    Lindy, Jan 31, 2018
    Replies:
    7
    Views:
    3,377
    RoxaneB
    Apr 9, 2018
  3. Rachel

    Shelf life vs Expiration date

    Rachel, Mar 17, 2016
    Replies:
    7
    Views:
    11,280
    Eric Twiname
    Mar 22, 2016
  4. Jimqa

    Best practice in tracking changes in Records

    Jimqa, Nov 15, 2021
    Replies:
    6
    Views:
    557
    Andy Nichols
    Nov 18, 2021
  5. ValeriaGar

    What do you think about Remote Audit during COVID 19?

    ValeriaGar, Dec 22, 2020
    Replies:
    6
    Views:
    1,327
    Jennifer Kirley
    Dec 31, 2020
  6. Greig

    ISO13485 - The correct standard for pharmaceutical packaging?

    Greig, Jul 3, 2018
    Replies:
    6
    Views:
    3,165
    Greig
    Nov 28, 2018
  7. Nikki

    How do I validate our ERP system?

    Nikki, Apr 12, 2016
    Replies:
    6
    Views:
    5,002
    AcTouch
    Aug 14, 2017
  8. JCIC49

    Use of Sharepoint for controlling documents

    JCIC49, Nov 27, 2015
    Replies:
    6
    Views:
    2,017
    Claes Gefvenberg
    Dec 1, 2015
  9. John C. Abnet

    Medical device Non-conformance based on ISO 14971 ?

    John C. Abnet, Nov 30, 2021
    Replies:
    5
    Views:
    776
    John C. Abnet
    Dec 1, 2021
  10. HeathW

    Is validation of training tools required?

    HeathW, Mar 26, 2021
    Replies:
    5
    Views:
    906
    HeathW
    Apr 1, 2021
  11. Garrett deBorst

    Looking to have an internal audit performed

    Garrett deBorst, Dec 1, 2020
    Replies:
    5
    Views:
    563
    Andy Nichols
    Dec 1, 2020
  12. Mike Bodine

    Understanding the difference between ISO 13485 and 21 CFR 820

    Mike Bodine, Jan 25, 2017
    Replies:
    5
    Views:
    2,633
    ValeriaGar
    Nov 3, 2020
  13. dr1vn

    Intentional reprocessing of a single use device

    dr1vn, Mar 18, 2016
    Replies:
    5
    Views:
    1,043
    Ronen E
    Mar 29, 2016
  14. Make-it-simple

    Corrective and/or Preventive Action Procedure

    Make-it-simple, Oct 2, 2015
    Replies:
    5
    Views:
    1,747
    Nikki
    Oct 5, 2015
  15. Rachel

    Do we need to have the word SHALL in our QMS as it is in ISO 13485 ?

    Rachel, Sep 2, 2015
    Replies:
    5
    Views:
    1,390
    Rachel
    Sep 8, 2015
  16. Jeremy B Maher

    ISO13485 Clause 8.3 and Sub-Clause 8.3.2 and 8.3.3

    Jeremy B Maher, Oct 26, 2023
    Replies:
    4
    Views:
    757
    Andy Nichols
    Nov 1, 2023
  17. KD Shah

    How to get ISO 13485

    KD Shah, Dec 6, 2019
    Replies:
    4
    Views:
    1,029
    ValeriaGar
    Nov 3, 2020
  18. Lindy

    MDSAP Registrar

    Lindy, Jan 18, 2019
    Replies:
    4
    Views:
    954
    Kymberly
    May 2, 2020
  19. Nikki

    Updating QM to 13485:2016 - We do not make medical devices

    Nikki, Sep 25, 2018
    Replies:
    4
    Views:
    1,367
    tony s
    Mar 22, 2019
  20. Karly Chester Etzel

    Design and Development Plan

    Karly Chester Etzel, Sep 25, 2018
    Replies:
    4
    Views:
    1,390
    Karly Chester Etzel
    Oct 9, 2018
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