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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. Nomi P

    Equipment SOPs

    Nomi P, Jan 28, 2016
    Replies:
    1
    Views:
    1,113
    yodon
    Jan 29, 2016
  2. Nikki

    Can I Exclude These 13485 requirements?

    Nikki, Jan 28, 2016
    Replies:
    1
    Views:
    772
    Ronen E
    Jan 28, 2016
  3. pcmc47

    Removing Non Value Added Inspection

    pcmc47, Jan 29, 2016
    Replies:
    2
    Views:
    1,056
    Bev D
    Jan 29, 2016
  4. Louise

    Critical Supplier Agreement

    Louise, Feb 1, 2016
    Replies:
    0
    Views:
    888
    Louise
    Feb 1, 2016
  5. QA Bee

    ISO 13485 Pre-Assessment

    QA Bee, Feb 11, 2016
    Replies:
    4
    Views:
    1,273
    QA Bee
    Feb 11, 2016
  6. Nash Jan

    ISO 10993-1: 2009 Annex A Biological Evaluation Tests

    Nash Jan, Feb 15, 2016
    Replies:
    3
    Views:
    2,741
    RW Soller
    Feb 14, 2017
  7. MarkMeer

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

    MarkMeer, Feb 29, 2016
    Replies:
    16
    Views:
    4,673
    MarkMeer
    Mar 22, 2016
  8. Steve Kent

    Quality Agreement

    Steve Kent, Mar 2, 2016
    Replies:
    3
    Views:
    1,498
    Marcelo Antunes
    Mar 4, 2016
  9. QA Bee

    ISO 13485 vs. EN ISO 13485

    QA Bee, Mar 14, 2016
    Replies:
    4
    Views:
    20,627
    Pads38
    Mar 15, 2016
  10. Rachel

    Shelf life vs Expiration date

    Rachel, Mar 17, 2016
    Replies:
    7
    Views:
    11,356
    Eric Twiname
    Mar 22, 2016
  11. dr1vn

    Intentional reprocessing of a single use device

    dr1vn, Mar 18, 2016
    Replies:
    5
    Views:
    1,046
    Ronen E
    Mar 29, 2016
  12. karenlin

    Every change required communication?

    karenlin, Apr 8, 2016
    Replies:
    3
    Views:
    1,097
    Jose Ramon Salazar
    Jun 20, 2017
  13. Nikki

    How do I validate our ERP system?

    Nikki, Apr 12, 2016
    Replies:
    6
    Views:
    5,005
    AcTouch
    Aug 14, 2017
  14. Nikki

    Do we have to validate every piece of new equipment?

    Nikki, Apr 18, 2016
    Replies:
    3
    Views:
    2,097
    Karl76
    Apr 29, 2016
  15. K Muela

    Purchasing data review requirements

    K Muela, Apr 26, 2016
    Replies:
    4
    Views:
    1,399
    matkins151
    Apr 28, 2016
  16. Nikki

    Validation during Design & Development

    Nikki, Apr 28, 2016
    Replies:
    1
    Views:
    783
    Ronen E
    Apr 28, 2016
  17. DarisQ

    New chapter 4.2.3 Medical Device file

    DarisQ, May 9, 2016
    Replies:
    4
    Views:
    4,865
    TerryMc
    Jul 15, 2016
  18. PoojaN

    ISO 13485 vs CFR 820

    PoojaN, May 26, 2016
    Replies:
    4
    Views:
    1,335
    Marc Smith
    May 27, 2016
  19. Nikki

    What is missing from my list for 13485 certification?

    Nikki, May 27, 2016
    Replies:
    9
    Views:
    1,804
    Vintage Goose
    Nov 23, 2016
  20. Jura1752

    ISO 13485 7.4.1 Purchasing Process

    Jura1752, Aug 7, 2016
    Replies:
    1
    Views:
    2,202
    yodon
    Aug 8, 2016
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