SOP Clinical Evaluation
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Use this SOP Clinical Evaluation template to systematically plan, conduct, and document the clinical evaluation process for your medical device, ensuring compliance with EU MDR 2017/745 and related guidance. This document is essential when bringing new products to market, updating clinical evidence, or responding to significant product or safety changes, and helps you demonstrate and maintain the required safety, performance, and benefit-risk evidence throughout the device lifecycle. Fill it out as part of your technical documentation to support conformity assessment and ongoing post-market surveillance activities.