IEC 62304 Templates

This collection contains working templates for an IEC 62304 medical-device software lifecycle. It helps structure the software development plan, requirements, architecture and detailed design, unit and integration work, verification, release, configuration management, problem resolution, maintenance, and the traceability that connects those activities.

Choose the records according to the software safety class and the role software plays in the device. Keep the software item and unit breakdown consistent across architecture, risk controls, implementation, tests, anomalies, and release evidence. For software of unknown provenance, document the identification, known anomalies, risk controls, and evaluation needed for its intended use.

IEC 62304 is only one part of a compliant software device. Coordinate these templates with ISO 14971 risk management, IEC 62366-1 usability engineering, cybersecurity, system-level verification and validation, clinical evaluation, post-market surveillance, and the applicable MDR, IVDR, or other market requirements. The examples are not a substitute for the standard or a development history. Adapt them to your tools and process, preserve review and approval evidence, and ensure the final records describe the software version you actually release.