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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. TKOMaine

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

    TKOMaine, Nov 9, 2021
    Replies:
    7
    Views:
    736
    Andy Nichols
    Nov 10, 2021
  2. Nikki

    Do we have to validate every piece of new equipment?

    Nikki, Apr 18, 2016
    Replies:
    3
    Views:
    2,099
    Karl76
    Apr 29, 2016
  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:
    1,398
    Rachel
    Sep 8, 2015
  4. OrangeIsEnergy

    Document & record retention times

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

    Does 13485:2016 - 7.2.3 Customer Communication include marketing?

    Qualityforum Mainar, Nov 10, 2017
    Replies:
    1
    Views:
    1,394
    yodon
    Nov 15, 2017
  6. 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
  7. John Thacher

    Doing Less Change Orders by Allowing Part Interchangeability

    John Thacher, Dec 16, 2020
    Replies:
    1
    Views:
    554
    yodon
    Dec 18, 2020
  8. Nomi P

    Equipment SOPs

    Nomi P, Jan 28, 2016
    Replies:
    1
    Views:
    1,113
    yodon
    Jan 29, 2016
  9. duff999

    Equipment validations

    duff999, Sep 26, 2019
    Replies:
    2
    Views:
    740
    duff999
    Aug 26, 2020
  10. karenlin

    Every change required communication?

    karenlin, Apr 8, 2016
    Replies:
    3
    Views:
    1,098
    Jose Ramon Salazar
    Jun 20, 2017
  11. ASFAR _to_ISOFDA

    FDA & ISO 13485 Customer Supplied Material

    ASFAR _to_ISOFDA, Jun 8, 2017
    Replies:
    1
    Views:
    743
    yodon
    Jun 9, 2017
  12. Rahul

    FDA registration and ISO 13485 recertification

    Rahul, Jan 5, 2016
    Replies:
    4
    Views:
    1,033
    Jim Hagenbaugh
    Jan 8, 2016
  13. 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
  14. Nikki

    How do I validate our ERP system?

    Nikki, Apr 12, 2016
    Replies:
    6
    Views:
    5,006
    AcTouch
    Aug 14, 2017
  15. 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
  16. Mandy

    How often to calibrate an analytical balance

    Mandy, Dec 6, 2015
    Replies:
    1
    Views:
    740
    Eric Twiname
    Dec 7, 2015
  17. KD Shah

    How to get ISO 13485

    KD Shah, Dec 6, 2019
    Replies:
    4
    Views:
    1,035
    ValeriaGar
    Nov 3, 2020
  18. Malius

    Infallibility of QA department?

    Malius, Nov 18, 2021
    Replies:
    10
    Views:
    1,228
    Jennifer Kirley
    Nov 23, 2021
  19. 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
  20. dr1vn

    Intentional reprocessing of a single use device

    dr1vn, Mar 18, 2016
    Replies:
    5
    Views:
    1,046
    Ronen E
    Mar 29, 2016
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