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
About the Author
Stephanie Knighten, MS is a manager of medical writing at Whitsell Innovations, Inc (WI). She has over 20 years of experience in regulatory writing including nonclinical and clinical documents for medical devices and pharmaceuticals. She leads WI’s team of writers that specialize in clinical evaluation reports and medical device submissions for the European Union and the US Food and Drug Administration.
