Discover the world of innovation and medical standards made easy, learn about the brand new ISO 22679 draft standard for cardiac occluders.
Lesson 2 – Device Design, pre-Clinical Testing and Risk
- Course Type: Video Lessons
- Language: English
- Level: Advanced
- Time: 0 - 1 Hour
- Session: year 2020
|Fundamental Requirements Device Design & Risk Mgt||00:06:30|
|Introduction and Key Assessments||00:05:27|
|Design Specific Testing||00:06:23|
|Design V&V in Vivo||00:05:53|
Exam and Certifications
- Final Test – Clinical Trial Design
Learning and following this standard, developers can perform a complete and correct assessment of the product’s physical, mechanical, chemical, and biological properties of transcatheter cardiac occluders and of their materials and components. Recommended in-vivo animal evaluations are also provided, including choice of animal model; study duration; device size; sample size; applicability and relevance based on similarities or differences between animal model and humans for devise use; and also, alternative implantation site or techniques.
Extensive guidelines are provided to design and conduct clinical trials, including imaging assessment, target population and follow-up duration and methods, as well as objective criteria for establishing safety, usability and clinical benefits.
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