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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

    How do I validate our ERP system?

    Nikki, Apr 12, 2016
    Replies:
    6
    Views:
    766
    AcTouch
    Aug 14, 2017
  2. MarkMeer

    What's the deal with MDSAP?

    MarkMeer, Dec 11, 2015
    Replies:
    10
    Views:
    666
    Ye Li
    Aug 1, 2017
  3. karenlin

    Every change required communication?

    karenlin, Apr 8, 2016
    Replies:
    3
    Views:
    316
    Jose Ramon Salazar
    Jun 20, 2017
  4. ASFAR _to_ISOFDA

    FDA & ISO 13485 Customer Supplied Material

    ASFAR _to_ISOFDA, Jun 8, 2017
    Replies:
    1
    Views:
    56
    yodon
    Jun 9, 2017
  5. James Elwood

    13485 and Signed Documents

    James Elwood, Apr 25, 2017
    Replies:
    3
    Views:
    169
    normzone
    Apr 29, 2017
  6. Mike Bodine

    Understanding the difference between ISO 13485 and 21 CFR 820

    Mike Bodine, Jan 25, 2017
    Replies:
    4
    Views:
    223
    Marcelo Antunes
    Apr 25, 2017
  7. Jantani1275

    Quality performing manufacturing

    Jantani1275, Apr 18, 2017
    Replies:
    1
    Views:
    87
    yodon
    Apr 18, 2017
  8. Nash Jan

    ISO 10993-1: 2009 Annex A Biological Evaluation Tests

    Nash Jan, Feb 15, 2016
    Replies:
    3
    Views:
    762
    RW Soller
    Feb 14, 2017
  9. Jose Ramon Salazar

    Calibrating maintenance equipment

    Jose Ramon Salazar, Feb 3, 2017
    Replies:
    9
    Views:
    230
    ncwalker
    Feb 14, 2017
  10. GregL

    ISO 13485: Suppliers to Medical Device company

    GregL, Dec 6, 2016
    Replies:
    7
    Views:
    381
    Vintage Goose
    Dec 16, 2016
  11. Nikki

    What is missing from my list for 13485 certification?

    Nikki, May 27, 2016
    Replies:
    9
    Views:
    522
    Vintage Goose
    Nov 23, 2016
  12. MonteS

    Must Medical Device Subcomponent Manufacturers Perform IQs and OQs on Existing Equipment?

    MonteS, Sep 27, 2016
    Replies:
    2
    Views:
    239
    Candi1024
    Oct 11, 2016
  13. fialor

    Country of Origin or "Made In" Tags

    fialor, Sep 14, 2016
    Replies:
    2
    Views:
    223
    RoxaneB
    Sep 14, 2016
  14. Jura1752

    ISO 13485 7.4.1 Purchasing Process

    Jura1752, Aug 7, 2016
    Replies:
    1
    Views:
    375
    yodon
    Aug 8, 2016
  15. DarisQ

    New chapter 4.2.3 Medical Device file

    DarisQ, May 9, 2016
    Replies:
    4
    Views:
    1,194
    TerryMc
    Jul 15, 2016
  16. PoojaN

    ISO 13485 vs CFR 820

    PoojaN, May 26, 2016
    Replies:
    4
    Views:
    453
    Marc Smith
    May 27, 2016
  17. Nikki

    Do we have to validate every piece of new equipment?

    Nikki, Apr 18, 2016
    Replies:
    3
    Views:
    425
    Karl76
    Apr 29, 2016
  18. Nikki

    Validation during Design & Development

    Nikki, Apr 28, 2016
    Replies:
    1
    Views:
    281
    Ronen E
    Apr 28, 2016
  19. K Muela

    Purchasing data review requirements

    K Muela, Apr 26, 2016
    Replies:
    4
    Views:
    303
    matkins151
    Apr 28, 2016
  20. Marcelo Antunes

    ISO 13485 Revision

    Marcelo Antunes, Aug 25, 2015 ... 2 3 4
    Replies:
    65
    Views:
    4,499
    Sue Place
    Apr 25, 2016
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