Description

The Clinical Evaluation Document Package is meticulously designed to assist organizations in conducting comprehensive clinical evaluations in compliance with Regulation (EU) 2017/745 (MDR) and MEDDEV 2.7/1 Rev. 4 guidelines. This package includes:

• Clinical Evaluation Plan (CEP): A structured document that establishes the criteria and methodology for assessing the clinical safety and performance of a medical device. It outlines the intended purpose, identifies the
• Clinical Evaluation Report (CER): A comprehensive report presenting the analysis of clinical data, demonstrating the device’s conformity with relevant GSPRs.
• Excel Tools: User-friendly spreadsheets designed to support data analysis and reporting throughout the clinical evaluation process.
• General Safety and Performance Requirements (GSPRs) Assessment Form