Short course on Clinical Investigation for Medical Devices and ISO 14155

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  • เผยแพร่เมื่อ 22 พ.ค. 2024
  • This is an excerpt from the course "Clinical Investigation for Medical Devices and ISO 14155" which is available at:
    medicaldevicehq.com/introduct...
    Starting October 2023, the templates mentioned in the video are no longer available for free on Medical Device HQ. However, more comprehensive paid versions are now accessible via this link:
    medicaldevicehq.com/templates/
    We offer premium templates for free to our newsletter subscribers. Instant access to some templates is granted upon subscription. Others will be distributed periodically as part of our newsletter email campaigns.
    Chapters:
    00:00 Introduction
    00:31 About the instructor
    01:15 Learning goals
    01:57 About the standard
    02:35 What is clinical investigation?
    04:52 Which medical devices need a clinical investigation?
    06:32 Good Clinical Practice - GCP
    07:41 ICH
    08:48 ISO 14155
    10:21 Stakeholders
    13:10 Summary of GCP principles
    15:25 Drugs vs. devices
    16:30 Clinical investigation milestones
    17:23 Budget
    18:10 Additional resources
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ความคิดเห็น • 3

  • @amosbabatundejayesimi6370
    @amosbabatundejayesimi6370 ปีที่แล้ว +1

    thank you so much, Maria. You just helped with my coursework.

  • @ramezani.sorkhi
    @ramezani.sorkhi ปีที่แล้ว

    Good words accompanying with brilliant sense by the instructor!

  • @petar9532
    @petar9532 ปีที่แล้ว

    Very proffesional, thank you.