Software testing & cybersecurity with prebuilt IEC templates.
Eliminate audit panic before major software releases. Straits binds automated test suites, branch coverage reports, and security scans directly to IEC 62304, SOC 2, and ISO 27001 clauses — delivering zero-friction continuous compliance.
Turnkey templates for medical software & cloud security
Select a template below to inspect its requirement hierarchy, automated test hooks, and regulatory outputs.
IEC 62304 Medical Device Software
Decomposes software architecture into safety classes, enforcing architectural isolation, unit acceptance criteria, and bidirectional risk management under ISO 14971.
Live Test Artifact & Evidence Traceability Matrix
Unit test execution logs, SAST security reports, and branch coverage metrics automatically linked to regulatory clauses.
Strict separation of duties under 21 CFR Part 11
Audit trails require undeniable proof that authors cannot self-approve pull requests. Straits enforces cryptographic role boundaries between developers, reviewers, and quality directors.
Authors feature commits, writes unit test assertions, and submits pull requests. System automatically links commits to requirement IDs.
Inspects static analysis vulnerability reports, checks MC/DC coverage thresholds, and validates that edge cases meet IEC standard safety requirements.
Applies FDA 21 CFR Part 11 digital cryptographic sign-off, locking the sprint baseline and minting an immutable SHA-256 release dossier.
Accelerate your software compliance lifecycle.
Book a technical consultation with James and the Straits compliance engineering team to connect your CI/CD test runners with prebuilt IEC templates.