Easy Feasibility – ISCTR | International Society for Cardiovascular Translational Research

Lecture – David Reuter, MD, Seattle Children’s Hospital

David Reuter, MD Director, Cardiac Innovation, Seattle Children’s Hospital Learning Objectives Understand the technical challenges and risk management Understand the importance of optimizing communication Learn the difference between innovation and research Understand the concept of design freeze

Lecture – Andrew Farb, MD, FDA

Andrew Farb, MD Medical Officer, Interventional Cardiology Devices Branch, FDA Learning Objectives Understand the importance of EFS in device development Understand the components of EFS Learn the limitation of non-clinical testing and doing the right test at the right time Learn the EFS pre-IDE submission timeline and goals Learn how EFS can expedite product approval […]

Topic Category: Easy Feasibility

Lecture – David Reuter, MD, Seattle Children’s Hospital

Lecture – Andrew Farb, MD, FDA

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