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ZiMT Journal Club November 2019: Dr. Miyuki Tauchi / Clinical evaluation

Stages of a clinical evaluation and references to sections and appendices of MEDDEV 2.7/1 revision 4.

Dr. Miyuki Tauchi, Internal Medicine II

Clinical evaluation

‘Clinical evaluation’ means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer (EU MDR 2017/745). Clinical evaluation is required for all medical devices to be marketed in the European economic area. The process comprises four steps: 1) pertinent data identification; 2) pertinent data appraisal; 3) clinical data analysis; 4) clinical evaluation report. Through the process, safety, benefit-risk profile, and performance of the device should be demonstrated and summarized in a clinical evaluation report.

Biography

Miyuki Tauchi studied Veterinary Medicine at the Obihiro University of Agriculture and Veterinary Medicine, Japan. After receiving her D.V.M. degree, she pursued a Master’s degree in the Department of Animal Science at Michigan State University, USA, and a Ph.D. in the Interdisciplinary Graduate Program for Neuroscience at the University of Cincinnati, USA. She gained research experience at the Institute of Anatomy II and the department of Neurology, University Hospital Erlangen, and works currently as the deputy head of the Laboratory for Molecular and Experimental Cardiology, University Hospital Erlangen. Since 2014 she has also been working as an independent medical writer and prepares clinical study-related documents in various disease fields for global pharmaceutical companies.

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