IEC 62304 and the software DHF: design controls and documentation that don't slow engineers down

IEC 62304 is the standard most SaMD teams need to comply with, but its language was written for a different era. Most teams end up running documentation as a parallel universe to development, then sprinting through cleanup before submission.

In this session from the Greenlight Guru Software Enabled Devices Virtual Summit, Shawnnah Monterrey of BeanStock Ventures translates IEC 62304 into practical terms and shows how to build a software DHF that engineers actually maintain. The session covers what each safety class (A, B, C) requires in practice, where teams over-engineer documentation that adds no regulatory value, and how to structure traceability across requirements, risk, and testing without duplicating Jira, GitHub, or your test framework.