Clinical Evaluation Report Basics from the Perspective of a Medical Writer

Clinical Evaluation Report Basics from the Perspective of a Medical Writer

White Paper

Clinical Evaluation Report Basics from the Perspective of a Medical Writer

In light of the evolving regulatory environment in the European Union (EU), we reexamine the fundamental principles of the Clinical Evaluation Report (CER) as outlined by Regulation 2017/745 (EU MDR) in this white paper. This overview of CER basics is offered through the lens of an experienced regulatory writer focusing on medical device submissions.

Clinical Evaluation Report Basics from the Perspective of a Medical Writer

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