Use this Technical File template for standalone medical device software to systematically document all required information for EU MDR and FDA compliance, including device description, intended use, risk management, design and development, software verification and validation, clinical evaluation, and post-market surveillance. Completing this template is essential prior to device submission or regulatory audit, as it ensures your technical documentation is comprehensive, traceable, and aligns with medical device regulatory requirements. This document is crucial for demonstrating conformity, supporting regulatory submissions, and facilitating Notified Body or FDA review of your software medical device.