For the EU market, all medical devices require an up-to-date Clinical Evaluation Report (CER). Notified bodies favor CERs featuring robust clinical data for CE marking purposes. This data must show that your device does what it is meant to do, safely.
Avania’s expert, qualified CER team will review your data to ensure compliance with the latest regulations (MEDDEV 2.7/1 rev. 4), gather and review the relevant supporting literature, and create your CER document. They will also help you ensure compliance by working with you to update your CER as needed, on an ongoing basis.
Learn more about Avania’s extensive Clinical Evaluation Report writing expertise.