End to End Requirements to Design Verification Test Traceability

A neurotechnology enterprise developing an implantable neurostimulator and wireless patient controller for chronic pain management.

complete bidirectional traceability achieved across 1,800: 100%complete bidirectional traceability achieved across 1,800
reduced regulatory submission audit preparation labor: 85%reduced regulatory submission audit preparation labor

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

Regulatory standards mandated complete bidirectional traceability from clinical hazards to design inputs, risk controls, and verification test protocols.
Traceability was maintained in static Word tables, where updating a single requirement required manually editing 40 separate cross reference links.
During a pre submission audit, auditors discovered 12 unverified risk control mitigations that lacked documented test results, jeopardizing FDA submission.

The run · 5 operational steps

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

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Tatvam establishes live bidirectional links between Clinical Hazards, Design Inputs, DFMEA Line Items, Risk Controls, and Test Protocols.

Input Signal:

Real-time operational telemetry & queue

Reasoning Pattern:

MCP grounded vector inference

Governance Gate:

Policy constrained with audit write-back

Verified Business Outcomes

100% complete bidirectional traceability achieved across 1,800 design inputs, risk controls, and test protocols.
Eliminated all traceability gaps and unverified risk mitigations prior to regulatory filing.
Reduced regulatory submission audit preparation labor by 85%.

Capabilities this relies on

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