Bluetooth
Medical Wearable Devices
93698259 Biomaterials Implantable Medical Devices and Biomedical Science
SENSOR DESIGN FOR MEDICAL DEVICES Luca Pollonini, Ph.D. COSC 7388 October 1 st, 2012.
FEDERAL REGULATIONS OF MEDICATIONS Food, Drug and Cosmetic Act Protect consumers from adulterated and misbranded foods, drugs, cosmetics, or devices.
Presented by: George Howe Executive Vice President Business Development & OEM Accounts.
UNCLASSIFIED Slide 1 of 37 FDA-Regulated Mobile Medical Apps LTC David Shoemaker, PhD, RAC Deputy Director, Division of Regulated Activities and Compliance.
1 Importation of Medical Devices FDA Chicago District O’Hare Import Resident Post August 26, 2010 Import Entry Review Team Tamara M. Qtami, CSO.
Compliance with FDA Regulations: Collecting, Transmitting and Managing Clinical Information Dan C Pettus Senior Vice President iMetrikus, Inc.
23andMe and FDA
Regulatory Pathway for Platform Technologies
Device Research Presented by Marian Serge, R.N.. Goals Identify devices Recognize difference between significant risk (SR) and non- significant risk (NSR)