Clearly Defining Measurable Safety and Performance Endpoints in Clinical Evaluation Reports (CER) is a Real Challenge for Medical Device Manufacturers
Author: Suzanne Broussard All medical devices sold in Europe must have a Clinical Evaluation Report (CER), and specific and measurable safety and performance endpoints are paramount for an acceptable CER. However, […]
What role does the CER play in getting a Medical Device Approved for Marketing in the EU?
Author: Suzanne Broussard Clinical evaluation is an integral part of technical documentation mandated for regulatory compliance of medical devices sold in the European Union (EU); therefore, having a well-designed and […]
Ask the Experts: What does MedDev 2.7/1 rev.4 mean for new and existing products?
Author: Douglas McGarvey Criterion Edge chats with regulatory authorities and other medical device and pharmaceutical industry experts to share their viewpoints on topics that impact our industry. With this expert […]
