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Genesis Cardiac Implant • 89 requirements
User Needs
Requirements
Design
Verification
Risks
Display analytics
R-wave sensitivity
Analytics algorithm
Catheter stress test
Vascular system
Battery monitoring
Thermal protection
Link needed
Temperature test
Thermal hazard
Data transmission
Bluetooth protocol
BLE stack
Range test
Data security
Full trace detected: UN-012 → REQ-078 → ALGO-004 → VT-092 → RISK-3
Gap detected: Missing design link between REQ-091 and VT-091 for thermal protection
Missing verification: VT-092 catheter stress test needs evidence
Compliance Standards Supported
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TRACE CHAIN
AI: AI linked: UN-012 → REQ-078 → ALGO-004. Missing: TR-031
TRACE CHAIN
AI: AI suggests: Link to RISK-31 for battery thermal protection
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Wearable ECG Monitor v2.1
Traceability Overview
LIVE7 gaps blocking DHF
Complete verification tests to generate audit-ready DHF
Available when all gaps are resolved
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