How Can a Systematic Literature Review (SLR) Help Prevent Common Pitfalls in Meeting the Elementary Requirements of Clinical Evaluation for MEDDEV 2.7/1 revision 4 Clinical Evaluation Report (CER)?
Author: Suzanne Broussard Performing a methodologically sound literature review in the early stages of product development, as well as in the later stages, can help reduce most of the inadequacies highlighted by the European Commission in section A6 of MEDDEV 2.7/1 […]
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 […]
