Description: After participating in this workshop, participants should be able to design and implement a strategy for developing a CER that is compliant with regulatory requirements and proactively addresses some common issues being raised by the Notified Bodies. Attendees will develop an in-depth understanding of the importance of assessing the product, indications, clinical evidence and state of the art while preparing, writing, revising and updating the CER.
Upon completion, participants should understand the European regulation and guidelines (MDR and relevant MEDDEV guidelines) pertaining to Clinical Evaluation Reports
Upon completion, participants should be able to prepare and draft a Clinical Evaluation Report according to the applicable requirements
Upon completion, participants will understand common Notified Body findings and how to prepare a strategy to address them within the CER.