Essential Guide to Clinical Evaluation Reports (CER) for Medical Devices

Essential Guide to Clinical Evaluation Reports (CER) for Medical Devices

Introduction In the intricate and regulated medical device manufacturing world, ensuring each product’s safety and efficacy is paramount. Clinical Evaluation Reports (CERs) are essential for demonstrating compliance with stringent safety and performance standards, especially within the European Union. These reports are a regulatory requirement and a moral obligation to guarantee patient safety. Understanding Clinical Evaluation…