- Introduction (00:01:02)
- What is ISO 20916:2019 (00:00:55)
- Scope and Normative References (00:01:05)
- Terms, Definitions, and Ethical Considerations (00:01:51)
- Clinical Performance Studies: Planning, Conduct & Close-out (00:07:35)
IVDR ISO 20916:2019
This lecture describes the key changes regarding post market surveillance and what companies should do to meet their new obligations. After the course you can take a final test to receive your certification. Enjoy!
Why take this course
This course supplements the IVDR with regard to the description of the organization, the roles involved and the requirements for conducting such a study.
What I will learn
This course will will guide you through ISO 20916 standard. You will learn it’s main topics and definitions. We will give you an overview of ethical principles and we will describe planning, conduct and close-out of clinical performance studies.
Skills I will gain
- Discover ISO 20916:2019
- Explore the main principles of ISO 20916:2019
- Learn how to ensure the conduct required for clinical performance studies
- Comprehend and apply the requirements of ISO 20196:2019 to In Vitro diagnostic medical device clinical studies
- Final Quiz – ISO 20916:2019
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