Renu Virmani, MD President, CV Path Institute Learning Objectives Understand the differences between animal model and human Learn the evaluation of the safety endpoints for decides in animal model Learn the timeline of histological evaluation and the method of evaluation Learn which animal model to use for what device Recognize the importance of different endpoints […]
Judith Davis, DVM, MS Senior Veterinary Medicine Reviewer, Cardiac Electrophysiology Devices Branch, FDA Learning Objectives Understand the risk assessment and mitigation of risk Learn how to plan and design animal study Understand the meaning of device performance and handling Learn the importance of early discussion with regulatory as early as possible Learn when animal study […]
Daniel Burkhoff, MD, PhD Adjunct Associate Professor of Medicine, Columbia University Learning Objectives Learn the device cycle development Understand the advantages and limitations of animal models Understand the important differences between different animals, small and large Understand the differences between animal model an a human anatomy and disease
Richard Rapoza, PhD Division VP of Research & Development, Abbot Vascular Learning Objectives Understand the important of anatomy and physiology during the design of the device Understand risk assessment and risk mitigation Learn about sterility, shelf life and packaging Learn the animal model for evaluation: acute, sub-acute, sub-chronic and chronic
Brad Quinn Acting Branch Chief, Cardiac Diagnostics Branch, FDA Learning Objectives Learn the component of design controls Understand design verification Understand design transfer Understand design validation Learn small scale manufacturing Understand Scalability
Todd Brinton, MD Chief Scientific Officer and Corporate Vice President, Edward Lifesciences Learning Objectives Recognize the process of innovation Understand the difference between innovation and clinical practice Understand concept generation Understand the value of innovation
