End to End Requirements to Design Verification Test Traceability
A neurotechnology enterprise developing an implantable neurostimulator and wireless patient controller for chronic pain management.
Run on Tatvam · Design Risk & FMEA
The challenge
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.
How Tatvam solves it
Bidirectional Digital Traceability Matrix
Tatvam establishes live bidirectional links between Clinical Hazards, Design Inputs, DFMEA Line Items, Risk Controls, and Test Protocols.
Automated Traceability Gap Detection
Continuously scans the traceability graph, instantly flagging any risk mitigation that lacks an approved verification test procedure.
Direct Test Management Tool Integration
Integrates with Jira, Azure DevOps, and test execution tools to pull live pass/fail test results directly into the DFMEA.
Impact Analysis for Test Failures
Highlights which specific clinical risk controls are compromised whenever a design verification bench test fails.
Audit Ready Traceability Matrix Export
Generates comprehensive, formatted, and clickable Traceability Matrices compliant with FDA guidance in seconds.
The outcome
- complete bidirectional traceability achieved across 1,800
- 0%complete bidirectional traceability achieved across 1,800
- reduced regulatory submission audit preparation labor
- 0%reduced regulatory submission audit preparation labor
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%.
Representative scenario: a modelled industry situation showing how this accelerator applies. Figures are projections, not a named client result.
Capabilities used
Every accelerator is assembled from the same capability layer, so a workflow you adopt here shares its foundation with the rest of the portfolio.
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