A Guide to Reporting and Data Mangement of Adverse Events involving Medical Devices

This book focuses on how to report and manage adverse events in medical devices, which is important to maintaining regulation compliance and safety of medical products. The author addresses how to recognize, document, and report adverse medical device events in a clear and accessible style. This book answers many of the questions sponsors and contract research organizations (CROs) frequently have about medical device development and requirements.
Because of the differences in regulations between pharmaceuticals and medical devices, this book fills a gap in the literature on the reporting and management of adverse events associated with medical devices.