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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. Mariah

    "Life Time of a Medical Device"

    Mariah, Dec 9, 2019
    Replies:
    0
    Views:
    861
    Mariah
    Dec 9, 2019
  2. James Elwood

    13485 and Signed Documents

    James Elwood, Apr 25, 2017
    Replies:
    4
    Views:
    1,258
    Quality Manager Liz
    Nov 24, 2017
  3. Nikki

    13485:2016 Internal Auditing Online Course?

    Nikki, Mar 8, 2019
    Replies:
    7
    Views:
    1,602
    Chaitany Thaker
    Apr 15, 2019
  4. Lindy

    3rd Party Supplier Audit in China: ISO 13485 & 21 CFR 820

    Lindy, Apr 17, 2019
    Replies:
    3
    Views:
    1,412
    Andy Nichols
    Apr 26, 2019
  5. Luca Ercolani

    Adobe Sign as digital signature tool

    Luca Ercolani, Jun 8, 2020
    Replies:
    2
    Views:
    1,569
    Steven Severt
    Sep 19, 2020
  6. Abdullah

    AQL

    Abdullah, Dec 28, 2015
    Replies:
    9
    Views:
    3,322
    DavidD
    Jan 5, 2016
  7. ChuckD

    Assigning Serial number at final QC check

    ChuckD, Sep 1, 2017
    Replies:
    2
    Views:
    875
    indicator
    Sep 7, 2017
  8. Jimqa

    Best practice in tracking changes in Records

    Jimqa, Nov 15, 2021
    Replies:
    6
    Views:
    543
    Andy Nichols
    Nov 18, 2021
  9. Jose Ramon Salazar

    Calibrating maintenance equipment

    Jose Ramon Salazar, Feb 3, 2017
    Replies:
    9
    Views:
    3,710
    ncwalker
    Feb 14, 2017
  10. Nikki

    Can I Exclude These 13485 requirements?

    Nikki, Jan 28, 2016
    Replies:
    1
    Views:
    766
    Ronen E
    Jan 28, 2016
  11. Airwolf

    CFU count for DI water sample

    Airwolf, Sep 20, 2019
    Replies:
    2
    Views:
    794
    Sam Lazzara
    Oct 4, 2019
  12. Kamil

    Clean Room Environments Specifications

    Kamil, Feb 22, 2021
    Replies:
    1
    Views:
    729
    Mary
    Jun 22, 2021
  13. QVarus

    Connecting Complaints and Risk Analysis

    QVarus, Aug 11, 2015
    Replies:
    3
    Views:
    1,005
    OrangeIsEnergy
    Aug 24, 2015
  14. Lindy

    Correcting Audit Findings

    Lindy, Jan 10, 2018 ... 2
    Replies:
    25
    Views:
    3,454
    BradM
    Jan 25, 2018
  15. Make-it-simple

    Corrective and/or Preventive Action Procedure

    Make-it-simple, Oct 2, 2015
    Replies:
    5
    Views:
    1,741
    Nikki
    Oct 5, 2015
  16. fialor

    Country of Origin or "Made In" Tags

    fialor, Sep 14, 2016
    Replies:
    2
    Views:
    870
    RoxaneB
    Sep 14, 2016
  17. Louise

    Critical Supplier Agreement

    Louise, Feb 1, 2016
    Replies:
    0
    Views:
    883
    Louise
    Feb 1, 2016
  18. Karly Chester Etzel

    Design and Development Plan

    Karly Chester Etzel, Sep 25, 2018
    Replies:
    4
    Views:
    1,357
    Karly Chester Etzel
    Oct 9, 2018
  19. TKOMaine

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

    TKOMaine, Nov 9, 2021
    Replies:
    7
    Views:
    688
    Andy Nichols
    Nov 10, 2021
  20. Nikki

    Do we have to validate every piece of new equipment?

    Nikki, Apr 18, 2016
    Replies:
    3
    Views:
    2,059
    Karl76
    Apr 29, 2016
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