Audit Ready Digital Risk Documentation & Regulatory Submission Readiness

A multinational orthopedic implant and surgical instrumentation manufacturer facing an unannounced EU MDR notified body quality system audit.

auditor document retrieval and demonstration time cut: 3 daysauditor document retrieval and demonstration time cut
external regulatory consulting and emergency audit remediation: $350,000external regulatory consulting and emergency audit remediation

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

Auditors requested immediate proof of risk management file evolution, design history file (DHF) traceability, and post market risk reassessments for 15 product lines.
Document retrieval from multiple file servers and paper archives took days, creating tension with regulatory inspection auditors.
Inconsistent document formatting and missing revision change rationales risked major non conformance audit findings.

The run · 5 operational steps

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

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Tatvam maintains all Risk Management Plans, DFMEAs, Hazard Analyses, and Risk Reports in a centralized 21 CFR Part 11 compliant vault.

Input Signal:

Real-time operational telemetry & queue

Reasoning Pattern:

MCP grounded vector inference

Governance Gate:

Policy constrained with audit write-back

Verified Business Outcomes

Auditor document retrieval and demonstration time cut from 3 days to under 30 seconds.
Successfully passed notified body EU MDR audit with zero non conformances or observations.
Saved $350,000 in external regulatory consulting and emergency audit remediation fees.

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