IEC 62304: Principles and Best Practices for Medical Device Firmware Development

Medical device software development is governed by IEC 62304, which mandates rigorous processes for development, testing, and risk management throughout the software lifecycle. This standard has an outsized impact on embedded firmware development, as it imposes extensive documentation and traceability demands.

This paper examines the core principles of IEC 62304, outlines key challenges in firmware development, and presents proven compliance approaches. We conclude by showing how DojoFive’s modern development practices and automated frameworks can help medical device manufacturers meet these challenges.