This document explains the role of the Summary of Technical Documentation (STED) in medical device regulatory submissions. It provides a harmonized framework for demonstrating conformity with safety and performance requirements under global regulations like EU MDR and FDA guidance. Key sections include device description, design verification, clinical evaluation, risk management, and labeling. IQVIA emphasizes the importance of structuring STED to support efficient audits and faster approvals. By aligning documentation with international standards, manufacturers can streamline submissions, reduce regulatory delays, and maintain compliance in a complex, evolving medtech environment.

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