GG VS Q2 2026 - IEC 62304 and the software DHF: design controls and documentation

IEC 62304 is the standard most SaMD teams need to comply with, but its language was written for a different era. Most teams over-engineer it and end up with documentation that runs parallel to development instead of coming out of it. This session translates IEC 62304 into practical terms for software teams. It covers what each safety class (A, B, C) actually requires, where teams waste effort on documentation that adds no regulatory value, and how to structure a software design history file (DHF) that engineers maintain as part of their normal workflow. The focus is on building documentation alongside development, not reconstructing it before submission. That means integrating requirements, risk, and testing into the tools your team already uses so traceability builds automatically as code ships. The session also addresses the most common DHF audit findings: broken requirement-to-test traceability, incomplete risk linkage, and gaps caused by doing compliance after development instead of during it.