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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. Qualityforum Mainar

    Does 13485:2016 - 7.2.3 Customer Communication include marketing?

    Qualityforum Mainar, Nov 10, 2017
    Replies:
    1
    Views:
    1,342
    yodon
    Nov 15, 2017
  2. OrangeIsEnergy

    Document & record retention times

    OrangeIsEnergy, Aug 10, 2015
    Replies:
    10
    Views:
    9,317
    OrangeIsEnergy
    Aug 13, 2015
  3. 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:
    1,384
    Rachel
    Sep 8, 2015
  4. Nikki

    Do we have to validate every piece of new equipment?

    Nikki, Apr 18, 2016
    Replies:
    3
    Views:
    2,072
    Karl76
    Apr 29, 2016
  5. TKOMaine

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

    TKOMaine, Nov 9, 2021
    Replies:
    7
    Views:
    715
    Andy Nichols
    Nov 10, 2021
  6. Karly Chester Etzel

    Design and Development Plan

    Karly Chester Etzel, Sep 25, 2018
    Replies:
    4
    Views:
    1,377
    Karly Chester Etzel
    Oct 9, 2018
  7. Louise

    Critical Supplier Agreement

    Louise, Feb 1, 2016
    Replies:
    0
    Views:
    884
    Louise
    Feb 1, 2016
  8. fialor

    Country of Origin or "Made In" Tags

    fialor, Sep 14, 2016
    Replies:
    2
    Views:
    875
    RoxaneB
    Sep 14, 2016
  9. Make-it-simple

    Corrective and/or Preventive Action Procedure

    Make-it-simple, Oct 2, 2015
    Replies:
    5
    Views:
    1,746
    Nikki
    Oct 5, 2015
  10. Lindy

    Correcting Audit Findings

    Lindy, Jan 10, 2018 ... 2
    Replies:
    25
    Views:
    3,530
    BradM
    Jan 25, 2018
  11. QVarus

    Connecting Complaints and Risk Analysis

    QVarus, Aug 11, 2015
    Replies:
    3
    Views:
    1,008
    OrangeIsEnergy
    Aug 24, 2015
  12. Kamil

    Clean Room Environments Specifications

    Kamil, Feb 22, 2021
    Replies:
    1
    Views:
    733
    Mary
    Jun 22, 2021
  13. Airwolf

    CFU count for DI water sample

    Airwolf, Sep 20, 2019
    Replies:
    2
    Views:
    801
    Sam Lazzara
    Oct 4, 2019
  14. flyonthewall

    CER Cleaning

    flyonthewall, Apr 24, 2024 at 6:19 PM
    Replies:
    1
    Views:
    86
    Andy Nichols
    Apr 24, 2024 at 8:42 PM
  15. Nikki

    Can I Exclude These 13485 requirements?

    Nikki, Jan 28, 2016
    Replies:
    1
    Views:
    767
    Ronen E
    Jan 28, 2016
  16. Jose Ramon Salazar

    Calibrating maintenance equipment

    Jose Ramon Salazar, Feb 3, 2017
    Replies:
    9
    Views:
    3,738
    ncwalker
    Feb 14, 2017
  17. Jimqa

    Best practice in tracking changes in Records

    Jimqa, Nov 15, 2021
    Replies:
    6
    Views:
    554
    Andy Nichols
    Nov 18, 2021
  18. ChuckD

    Assigning Serial number at final QC check

    ChuckD, Sep 1, 2017
    Replies:
    2
    Views:
    882
    indicator
    Sep 7, 2017
  19. Abdullah

    AQL

    Abdullah, Dec 28, 2015
    Replies:
    9
    Views:
    3,340
    DavidD
    Jan 5, 2016
  20. Luca Ercolani

    Adobe Sign as digital signature tool

    Luca Ercolani, Jun 8, 2020
    Replies:
    2
    Views:
    1,574
    Steven Severt
    Sep 19, 2020
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