A Bulletproof Clinical Evaluation Report: Making them stand up to regulatory scrutiny Mar 21, 2019
As Europe transitions to the MDR and TGA focuses more on clinical evidence in applications, creating a Clinical Evaluation Report (CER) that meets all regulators’ expectations seems like an impossibility. Understanding MEDDEV 2.7/1 revision 4 is difficult enough, without having to consider individual requirements of the individual regulators. Hope is not lost, a single report that will meet the various regulatory body’s scrutiny can be created.
Join T.J. Thiel and Heyam Kalla as they provide guidance in navigating the world of Clinical Evaluation Report and the MEDDEV 2.7/1 revision 4 guidance. Heyam and T.J. will discuss the items on which manufacturers and sponsors should focus, based on recent feedback from European Notified Bodies and TGA review. This webinar will help the audience understand how to create a CER that is complete and meets all regulatory expectations, particularly those that are not expressly written into the guidance.
Presented by: TJ Thiel and Heyam Kalla, Brandwood Biomedical