Medical Devices (IEC 62304, FDA, CE)
Deterministic Traceability: From Requirement to Code Commit
IEC 62304 Class B/C Compliance: Complete traceability for FDA/CE certification
Traceability Flow: Requirement → Compliance
Requirement
REQ-MED-001:
Heart Rate ±2bpm→
Architecture
ARCH-SW-045:
Signal Pipeline→
Implementation
Git Commit:
a3f7b2c→
Verification
TEST-VER-128:
Passed (95%)→
Compliance
IEC 62304 Class B ✓🎯 Audit Preparation: From 4 Weeks to 4 Hours
The graph automatically generates the compliance report: Every requirement, every test, every code commit — completely linked and verifiable by hash. Auditors get real-time answers to traceability questions.
Traceability Matrix Visualization (Interactive compliance documentation — coming soon)