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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. QA Bee

    ISO 13485 vs. EN ISO 13485

    QA Bee, Mar 14, 2016
    Replies:
    4
    Views:
    20,631
    Pads38
    Mar 15, 2016
  2. Marcelo Antunes

    ISO 13485 Revision

    Marcelo Antunes, Aug 25, 2015 ... 2 3 4
    Replies:
    65
    Views:
    12,178
    Sue Place
    Apr 25, 2016
  3. Rachel

    Shelf life vs Expiration date

    Rachel, Mar 17, 2016
    Replies:
    7
    Views:
    11,364
    Eric Twiname
    Mar 22, 2016
  4. OrangeIsEnergy

    Document & record retention times

    OrangeIsEnergy, Aug 10, 2015
    Replies:
    10
    Views:
    9,376
    OrangeIsEnergy
    Aug 13, 2015
  5. Nikki

    How do I validate our ERP system?

    Nikki, Apr 12, 2016
    Replies:
    6
    Views:
    5,006
    AcTouch
    Aug 14, 2017
  6. DarisQ

    New chapter 4.2.3 Medical Device file

    DarisQ, May 9, 2016
    Replies:
    4
    Views:
    4,866
    TerryMc
    Jul 15, 2016
  7. MarkMeer

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

    MarkMeer, Feb 29, 2016
    Replies:
    16
    Views:
    4,680
    MarkMeer
    Mar 22, 2016
  8. Jose Ramon Salazar

    Calibrating maintenance equipment

    Jose Ramon Salazar, Feb 3, 2017
    Replies:
    9
    Views:
    3,800
    ncwalker
    Feb 14, 2017
  9. Lindy

    Correcting Audit Findings

    Lindy, Jan 10, 2018 ... 2
    Replies:
    25
    Views:
    3,643
    BradM
    Jan 25, 2018
  10. Lindy

    On-site Supplier Audit Checklist

    Lindy, Jan 31, 2018
    Replies:
    7
    Views:
    3,416
    RoxaneB
    Apr 9, 2018
  11. Abdullah

    AQL

    Abdullah, Dec 28, 2015
    Replies:
    9
    Views:
    3,364
    DavidD
    Jan 5, 2016
  12. GregL

    ISO 13485: Suppliers to Medical Device company

    GregL, Dec 6, 2016
    Replies:
    8
    Views:
    3,267
    indicator
    Sep 7, 2017
  13. Nikki

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

    Nikki, Dec 4, 2015 ... 2
    Replies:
    23
    Views:
    3,266
    John C. Abnet
    Nov 5, 2020
  14. Greig

    ISO13485 - The correct standard for pharmaceutical packaging?

    Greig, Jul 3, 2018
    Replies:
    6
    Views:
    3,194
    Greig
    Nov 28, 2018
  15. RICHARD GALLAGHER

    Product Design Project Checklist?

    RICHARD GALLAGHER, Dec 11, 2015
    Replies:
    10
    Views:
    3,008
    QAengineer13
    Feb 3, 2016
  16. MarkMeer

    What's the deal with MDSAP?

    MarkMeer, Dec 11, 2015
    Replies:
    11
    Views:
    2,950
    Lindy
    Jan 26, 2018
  17. Nikki

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

    Nikki, Jun 18, 2018
    Replies:
    7
    Views:
    2,929
    John C. Abnet
    Jun 19, 2018
  18. MIGUEL LUNA

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

    MIGUEL LUNA, Jan 28, 2020
    Replies:
    9
    Views:
    2,861
    MIGUEL LUNA
    Jan 30, 2020
  19. Nash Jan

    ISO 10993-1: 2009 Annex A Biological Evaluation Tests

    Nash Jan, Feb 15, 2016
    Replies:
    3
    Views:
    2,742
    RW Soller
    Feb 14, 2017
  20. Mike Bodine

    Understanding the difference between ISO 13485 and 21 CFR 820

    Mike Bodine, Jan 25, 2017
    Replies:
    5
    Views:
    2,655
    ValeriaGar
    Nov 3, 2020
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