Medical Device Product Development Involving Sensors
(Room 103 AB)
11 Jun 15
10:10 AM
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10:50 AM
The development of medical devices presents unique regulatory challenges, compounded by the evolving landscape associated with integrated remote sensor technologies and closely related topics of patient safety and usability. The session aims to educate attendees on the challenges, as well as exemplify solutions, in the development of FDA regulated devices. In this session, attendees will receive an overview of U.S. Regulatory requirements associated with medical devices involving sensors, including software; current FDA indications of how apps, devices, and cloud services will be regulated. Attendees will also gain an appreciation of verification and validation requirements & methodologies required in medical device development and understand the impact of usability and related requirements in medical device development.