
CONNECTED DEVICES IN HEALTHCARE FDA LAWS: CLINICAL GRADE WEARABLES FOR IMPROVING PATIENT OUTCOMES
October 10, 2017 |
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
http://www.cbinet.com/sites/default/files/brochures/fc17214_brochure.pdf
Filed Under: FDA, Healthcare, Pharmaceuticals