About this document
Medical Device Clinical Evaluation SOP by Adil Husain is a document available to read on EtoBox.
This SOP outlines the development of medical devices in compliance with MDD and MDR regulatory requirements, focusing on clinical performance and safety. It details the process for creating a Clinical Evaluation Plan, conducting a Clinical Evaluation Report, and implementing a Post-Market Clinical Follow-Up to ensure ongoing safety and effectiveness. The Medical Team is responsible for these evaluations, with involvement from external partners as needed to enhance expertise and reduce regulatory risks.
- Author
- Adil Husain
- Language
- EN