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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. Rahul

    FDA registration and ISO 13485 recertification

    Rahul, Jan 5, 2016
    Replies:
    4
    Views:
    1,016
    Jim Hagenbaugh
    Jan 8, 2016
  2. laden

    Record Management (paper-based document system)

    laden, Apr 21, 2020
    Replies:
    9
    Views:
    1,012
    Mike S.
    Apr 29, 2020
  3. QVarus

    Connecting Complaints and Risk Analysis

    QVarus, Aug 11, 2015
    Replies:
    3
    Views:
    1,005
    OrangeIsEnergy
    Aug 24, 2015
  4. MonteS

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

    MonteS, Sep 27, 2016
    Replies:
    2
    Views:
    953
    Candi1024
    Oct 11, 2016
  5. Lindy

    MDSAP Registrar

    Lindy, Jan 18, 2019
    Replies:
    4
    Views:
    939
    Kymberly
    May 2, 2020
  6. Jimbo11

    Preparation For Upcoming External Audit 13485

    Jimbo11, Sep 3, 2018
    Replies:
    3
    Views:
    929
    Andy Nichols
    Sep 4, 2018
  7. Renaz

    PFMEA in low volume medical device manufacturing

    Renaz, Oct 20, 2018
    Replies:
    2
    Views:
    922
    John C. Abnet
    Oct 22, 2018
  8. QA Bee

    Risk Management Process

    QA Bee, Jan 5, 2016
    Replies:
    4
    Views:
    897
    QA Bee
    Jan 6, 2016
  9. HeathW

    Is validation of training tools required?

    HeathW, Mar 26, 2021
    Replies:
    5
    Views:
    892
    HeathW
    Apr 1, 2021
  10. Louise

    Critical Supplier Agreement

    Louise, Feb 1, 2016
    Replies:
    0
    Views:
    883
    Louise
    Feb 1, 2016
  11. ChuckD

    Assigning Serial number at final QC check

    ChuckD, Sep 1, 2017
    Replies:
    2
    Views:
    875
    indicator
    Sep 7, 2017
  12. fialor

    Country of Origin or "Made In" Tags

    fialor, Sep 14, 2016
    Replies:
    2
    Views:
    870
    RoxaneB
    Sep 14, 2016
  13. Mariah

    "Life Time of a Medical Device"

    Mariah, Dec 9, 2019
    Replies:
    0
    Views:
    862
    Mariah
    Dec 9, 2019
  14. Susan7

    Supply for Medical Device - ISO 13485

    Susan7, Mar 21, 2019
    Replies:
    3
    Views:
    825
    tony s
    Mar 22, 2019
  15. Airwolf

    CFU count for DI water sample

    Airwolf, Sep 20, 2019
    Replies:
    2
    Views:
    795
    Sam Lazzara
    Oct 4, 2019
  16. Nikki

    Validation during Design & Development

    Nikki, Apr 28, 2016
    Replies:
    1
    Views:
    773
    Ronen E
    Apr 28, 2016
  17. Nikki

    Can I Exclude These 13485 requirements?

    Nikki, Jan 28, 2016
    Replies:
    1
    Views:
    766
    Ronen E
    Jan 28, 2016
  18. John C. Abnet

    Medical device Non-conformance based on ISO 14971 ?

    John C. Abnet, Nov 30, 2021
    Replies:
    5
    Views:
    761
    John C. Abnet
    Dec 1, 2021
  19. Lindy

    ISO 13485:2016 Procedures in China

    Lindy, Nov 4, 2019
    Replies:
    1
    Views:
    758
    Golfman25
    Nov 4, 2019
  20. ankit

    Need this standard-Help

    ankit, Oct 11, 2017
    Replies:
    1
    Views:
    742
    Atul Khandekar
    Oct 11, 2017
Showing threads 61 to 80 of 103

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