When an engineering team manages product risk in isolated Excel rows, safety becomes a bureaucratic afterthought. In reality, risk is an interconnected web of physical hazards, software edge cases, manufacturing variances, and patient use conditions. PMX Risk Intelligence transforms static FMEAs into a continuous, closed-loop safety architecture that responds dynamically to every commit, test run, and field event.
Analyzing the fatal limitations of tabular risk management in complex electro-mechanical, software-driven medical devices.
An FMEA spreadsheet cell states: "Mitigation: Implement dual-sensor hardware comparator." But is that comparator actually in the BOM? Is it routed on PCB Rev D? Is there an automated test verifying its trip point? In Excel, there is zero programmatic link between the stated risk control and the physical design.
Real hazards are non-linear. A low-voltage brownout causes an ADC timing jitter, which causes an algorithm filter overflow, which delays an apnea alarm. Spreadsheets cannot model multi-layer causal chains or feedback loops. They force multi-dimensional physics into flat, artificial rows.
ISO 14971:2019 Clause 9 explicitly mandates continuous post-production monitoring. Yet when clinical complaints or MDR adverse events arrive, companies rarely reopen their Excel FMEAs to recalibrate estimated Occurrence scores, creating severe audit non-compliance.
Every risk element exists as an ontological vertex linked continuously to physical design controls and empirical evidence.
Click any cell to inspect active risks, residual mitigations, and ALARP acceptability determinations on CardioSense Pro v3.8.2.
Initial State: Severity 4 (Critical) × Occurrence 2 (Remote) → After implementation of REQ-0184 and dual-sensor comparator cutoff, Residual State: Severity 2 (Minor) × Occurrence 1 (Improbable). Risk Acceptability: ALARP Verified & Accepted by Lead Risk Officer.
PMX AI monitors all engineering changes to flag unmitigated safety hazards before an ECO is routed for formal Part 11 sign-off.
Triggered by proposed replacement of Thermistor S-18 with Digital Sensor S-22
"The proposed S-22 digital temperature sensor draws 4.2mA during its 16-bit calibration cycle, compared to 1.1mA for the S-18 thermistor. In single-fault scenarios with continuous bus lockup, thermal dissipation in the southeast corner of the chassis increases by +0.32W. Under 38.0°C ambient conditions, surface temperature may reach 41.4°C, breaching the REQ-0184 limit (<41.0°C)."
FW-SEC-92) forcing S-22 deep-sleep mode after 50ms of bus inactivity.
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Empower your systems engineering and quality teams with continuous ISO 14971 risk traceability that proves patient safety on every release.