CONNECTED DEVICES IN HEALTHCARE FDA LAWS: CLINICAL GRADE WEARABLES FOR IMPROVING PATIENT OUTCOMES

October 10, 2017 | Al Mohajerian

December 4-5, 2017 • Westin San Diego • San Diego, CA

Overview of FDA Regulatory Compliance Requirements — Spotlight on
Wearable Devices

Overview of FDA regulatory compliance requirements of wearable devices including hearing aids, defibrillator vests, radiation- emitting devices, watches, glasses and shoes
Medical device registration and FDA tracking
Risk-benefit analysis, preclinical studies, biocompatibility and biological evaluation
Classification, premarket submission

Al Mohajerian, Mohajerian APLC

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