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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. Kishnu Vaarma ROSS

    ISO 13485

    Kishnu Vaarma ROSS, Nov 3, 2022
    Replies:
    3
    Views:
    1,885
    Kishnu Vaarma ROSS
    Nov 14, 2022
  2. Nash Jan

    ISO 10993-1: 2009 Annex A Biological Evaluation Tests

    Nash Jan, Feb 15, 2016
    Replies:
    3
    Views:
    2,733
    RW Soller
    Feb 14, 2017
  3. HeathW

    Is validation of training tools required?

    HeathW, Mar 26, 2021
    Replies:
    5
    Views:
    904
    HeathW
    Apr 1, 2021
  4. yzl1018

    Is there any Brazilian biosafety standard or regulation?

    yzl1018, Dec 18, 2021
    Replies:
    0
    Views:
    1,837
    yzl1018
    Dec 18, 2021
  5. AdaTW22

    Is a software platform a medical device???

    AdaTW22, Mar 9, 2020
    Replies:
    2
    Views:
    2,590
    Maryna
    Jun 9, 2020
  6. dr1vn

    Intentional reprocessing of a single use device

    dr1vn, Mar 18, 2016
    Replies:
    5
    Views:
    1,038
    Ronen E
    Mar 29, 2016
  7. MIGUEL LUNA

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

    MIGUEL LUNA, Jan 28, 2020
    Replies:
    9
    Views:
    2,825
    MIGUEL LUNA
    Jan 30, 2020
  8. Malius

    Infallibility of QA department?

    Malius, Nov 18, 2021
    Replies:
    10
    Views:
    1,209
    Jennifer Kirley
    Nov 23, 2021
  9. KD Shah

    How to get ISO 13485

    KD Shah, Dec 6, 2019
    Replies:
    4
    Views:
    1,024
    ValeriaGar
    Nov 3, 2020
  10. Mandy

    How often to calibrate an analytical balance

    Mandy, Dec 6, 2015
    Replies:
    1
    Views:
    734
    Eric Twiname
    Dec 7, 2015
  11. Nikki

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

    Nikki, Dec 4, 2015 ... 2
    Replies:
    23
    Views:
    3,239
    John C. Abnet
    Nov 5, 2020
  12. Nikki

    How do I validate our ERP system?

    Nikki, Apr 12, 2016
    Replies:
    6
    Views:
    4,987
    AcTouch
    Aug 14, 2017
  13. Nikki

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

    Nikki, Jun 18, 2018
    Replies:
    7
    Views:
    2,881
    John C. Abnet
    Jun 19, 2018
  14. Rahul

    FDA registration and ISO 13485 recertification

    Rahul, Jan 5, 2016
    Replies:
    4
    Views:
    1,021
    Jim Hagenbaugh
    Jan 8, 2016
  15. ASFAR _to_ISOFDA

    FDA & ISO 13485 Customer Supplied Material

    ASFAR _to_ISOFDA, Jun 8, 2017
    Replies:
    1
    Views:
    737
    yodon
    Jun 9, 2017
  16. karenlin

    Every change required communication?

    karenlin, Apr 8, 2016
    Replies:
    3
    Views:
    1,081
    Jose Ramon Salazar
    Jun 20, 2017
  17. duff999

    Equipment validations

    duff999, Sep 26, 2019
    Replies:
    2
    Views:
    734
    duff999
    Aug 26, 2020
  18. Nomi P

    Equipment SOPs

    Nomi P, Jan 28, 2016
    Replies:
    1
    Views:
    1,112
    yodon
    Jan 29, 2016
  19. John Thacher

    Doing Less Change Orders by Allowing Part Interchangeability

    John Thacher, Dec 16, 2020
    Replies:
    1
    Views:
    549
    yodon
    Dec 18, 2020
  20. MarkMeer

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

    MarkMeer, Feb 29, 2016
    Replies:
    16
    Views:
    4,654
    MarkMeer
    Mar 22, 2016
Showing threads 61 to 80 of 105

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