Core clinical engineering and protocols for Automated IEC 62304 CI/CD.
Traditionally, preparing a medical software release for an FDA audit required weeks of tedious manual paperwork: manually copying test results into Word documents, tracing software requirements to test cases in Excel spreadsheets, and obtaining physical pen-and-paper signatures. SaMDOps replaces this manual bottleneck with fully automated CI/CD pipelines.
Every git commit, pull request approval, and test run is cryptographically signed using digital certificates conforming to FDA 21 CFR Part 11 (electronic records and electronic signatures). The pipeline automatically outputs an immutable, audit-ready Software Verification Report (SVR) containing 100% test execution logs and code coverage metrics.