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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. Marcelo Antunes

    ISO 13485 Revision

    Marcelo Antunes, Aug 25, 2015 ... 2 3 4
    Replies:
    65
    Views:
    12,084
    Sue Place
    Apr 25, 2016
  2. Lindy

    Correcting Audit Findings

    Lindy, Jan 10, 2018 ... 2
    Replies:
    25
    Views:
    3,559
    BradM
    Jan 25, 2018
  3. Nikki

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

    Nikki, Dec 4, 2015 ... 2
    Replies:
    23
    Views:
    3,247
    John C. Abnet
    Nov 5, 2020
  4. MarkMeer

    Does requirement to validate QMS software rule-out cloud-based apps?

    MarkMeer, Feb 29, 2016
    Replies:
    16
    Views:
    4,659
    MarkMeer
    Mar 22, 2016
  5. Nikki

    Looking to impress at new job

    Nikki, Aug 25, 2020
    Replies:
    13
    Views:
    1,691
    Andy Nichols
    Oct 15, 2020
  6. MarkMeer

    What's the deal with MDSAP?

    MarkMeer, Dec 11, 2015
    Replies:
    11
    Views:
    2,931
    Lindy
    Jan 26, 2018
  7. Malius

    Infallibility of QA department?

    Malius, Nov 18, 2021
    Replies:
    10
    Views:
    1,216
    Jennifer Kirley
    Nov 23, 2021
  8. RICHARD GALLAGHER

    Product Design Project Checklist?

    RICHARD GALLAGHER, Dec 11, 2015
    Replies:
    10
    Views:
    2,986
    QAengineer13
    Feb 3, 2016
  9. OrangeIsEnergy

    Document & record retention times

    OrangeIsEnergy, Aug 10, 2015
    Replies:
    10
    Views:
    9,333
    OrangeIsEnergy
    Aug 13, 2015
  10. laden

    Record Management (paper-based document system)

    laden, Apr 21, 2020
    Replies:
    9
    Views:
    1,032
    Mike S.
    Apr 29, 2020
  11. MIGUEL LUNA

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

    MIGUEL LUNA, Jan 28, 2020
    Replies:
    9
    Views:
    2,827
    MIGUEL LUNA
    Jan 30, 2020
  12. Jose Ramon Salazar

    Calibrating maintenance equipment

    Jose Ramon Salazar, Feb 3, 2017
    Replies:
    9
    Views:
    3,763
    ncwalker
    Feb 14, 2017
  13. Nikki

    What is missing from my list for 13485 certification?

    Nikki, May 27, 2016
    Replies:
    9
    Views:
    1,797
    Vintage Goose
    Nov 23, 2016
  14. Abdullah

    AQL

    Abdullah, Dec 28, 2015
    Replies:
    9
    Views:
    3,350
    DavidD
    Jan 5, 2016
  15. Abdullah

    Qualification of HVAC system

    Abdullah, Dec 27, 2015
    Replies:
    9
    Views:
    1,400
    Jennifer Kirley
    Dec 29, 2015
  16. GregL

    ISO 13485: Suppliers to Medical Device company

    GregL, Dec 6, 2016
    Replies:
    8
    Views:
    3,251
    indicator
    Sep 7, 2017
  17. Nikki

    Should we keep ISO 9001:2015 when we go for 13485 certification?

    Nikki, Jan 18, 2016
    Replies:
    8
    Views:
    1,823
    Scott K
    Feb 9, 2016
  18. TKOMaine

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

    TKOMaine, Nov 9, 2021
    Replies:
    7
    Views:
    724
    Andy Nichols
    Nov 10, 2021
  19. JakobA

    Looking for test people

    JakobA, Mar 2, 2021
    Replies:
    7
    Views:
    723
    JakobA
    Mar 12, 2021
  20. Nikki

    13485:2016 Internal Auditing Online Course?

    Nikki, Mar 8, 2019
    Replies:
    7
    Views:
    1,619
    Chaitany Thaker
    Apr 15, 2019
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