For Software Teams Building Medical
Devices Without a Regulatory Playbook
18 templates for IEC 62304 software lifecycle, SOUP documentation, and FDA SaMD guidance
Your auditor asks for your SOUP list. You hand over a spreadsheet with package names and versions.
"Where is the risk analysis for each SOUP item? Where is the verification that the published anomalies do not affect your safety claims?" You realize your software engineers have been treating regulatory documentation like an afterthought.
What if your software documentation was built for how auditors actually evaluate IEC 62304 compliance?
We mapped IEC 62304 to real audit findings:
Every clause requirement. Every FDA guidance expectation. Every common SaMD audit finding. Templates structured around software safety classification, SOUP risk management, and the specific documentation artifacts auditors are trained to check.
What is Included: 18 SaMD Templates