Thermal and Electrical Hazard Prioritization & Residual Risk Mitigation

An electro medical device manufacturer producing a high frequency electrosurgical generator and radiofrequency tissue ablation workstation.

residual risk evaluation and design freeze sign off accelerated: 6 weeksresidual risk evaluation and design freeze sign off accelerated
high severity thermal and electrical hazards mitigated: 100%high severity thermal and electrical hazards mitigated

How the work runs

The pressure that made this worth automating, the steps the system runs, and what came out the other side.

Pressure & Trigger Points

The device delivered high energy RF currents, creating severe thermal injury, capacitive coupling, and electromagnetic interference (EMI) hazards.
Engineers struggled to quantify whether combined risk mitigations reduced the residual patient risk to an acceptable level per ALARP (As Low As Reasonably Practicable) criteria.
Subjective risk scoring in spreadsheets led to prolonged debates between R&D; engineers and Quality Assurance directors, stalling design freezes.

The run · 5 operational steps

Click any step to inspect telemetry signals, model reasoning, and governance gates.

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Tatvam categorizes thermal, electrical, radiation, and biological hazards into structured hazard tree hierarchies.

Input Signal:

Real-time operational telemetry & queue

Reasoning Pattern:

MCP grounded vector inference

Governance Gate:

Policy constrained with audit write-back

Verified Business Outcomes

Residual risk evaluation and design freeze sign off accelerated from 6 weeks to 4 business days.
100% of high severity thermal and electrical hazards mitigated to verified acceptable ALARP levels.
Zero design modifications required during external IEC 60601 1 medical electrical safety testing.

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