- Fundamental Requirements Device Design & Risk Mgt (06:30)
- Introduction and Key Assessments (05:27)
- Design Specific Testing (06:23)
- Design V&V in Vivo (05:53)
Lesson 2 – Device Design, Pre-Clinical Testing and Risk
Discover the world of innovation and medical standards made easy, learn about the brand new ISO 22679 draft standard for cardiac occluders.
The structural heart occluders market is expanding rapidly and a new wave of technologies are being developed to enhance the transcatheter treatment of congenital or iatrogenic disorders such as atrial and ventricular septal defects, patent foramen ovale, left atrial appendage closure and paravalvular leak. Given the lack of commonly accepted methodologies to establish safety and performance of cardiac occluders, there is and urgent need for guidance in this sector.
This new, exclusive course, will present for the first time an outline of the new ISO 22679 draf standard for transcatheter cardiac occluders, that can be used to produce a risk based strategy for accelerating the development, validation, and approval of occluders in the global market. In-depth guidance is provided for all steps of the product lifecycle, from design to preclinical validation and clinical trials. You will learn the step-by-step tools needed to conduct and complete the required product assessments, as well as the recommended in-vitro animal evaluations, alternative implantation techniques, pathways to clinical trial development, and more. The skills gained during the course will help guide you forward in applying the new standard that establishes effective safety and performance of cardiac occluders.
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.
- Final Test – Clinical Trial Design
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