Planning, Writing and Reviewing Medical Device Clinical and Performance Evaluation Reports (CERs/PERs) guides readers through clinical data evaluation of medical devices and performance evaluations for in vitro diagnostic devices in compliance with European Union Medical Device Regulation and other similar regulatory requirements throughout the world. This book brings together knowledge learned while the author constructed hundreds of CERs/PERs and taught thousands of learners how to conduct clinical and performance data evaluations. It supports training for clinical evaluators, clinical engineers, clinical. evaluation scientists, and experts reviewing medical device CERs and PERs. This book is designed to help individual writers, teams, and companies to develop stronger, more robust CERs and PERs. Key Features Identifies and explains clinical data analysis techniques for clinical evaluations of medical devices and performance evaluations for in vitro diagnostic devices, Teaches readers how to understand and evaluate medical device safety and performance in the context of global regulations, Provides a deep dissection of clinical evaluation criteria in the context of medical device design as well as in-hospital and at-home deployment and servicing.