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.
Run on Tatvam · Design Risk & FMEA
The challenge
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.
How Tatvam solves it
Unified Digital Risk Management Vault
Tatvam maintains all Risk Management Plans, DFMEAs, Hazard Analyses, and Risk Reports in a centralized 21 CFR Part 11 compliant vault.
Immutable Version History & Change Rationales
Records every risk score modification, author rationale, and timestamped electronic signature in an unalterable audit trail.
Live Auditor Read Only Presentation Portal
Provides inspection auditors with secure, read only portal access to inspect interactive risk traceability graphs and test evidence.
Instant Regulatory Standard Cross Mapping
Maps risk management records against ISO 14971:2019, ISO 13485:2016, and EU MDR Annex I General Safety and Performance Requirements (GSPR).
One Click Technical File Compilation
Publishes standardized, professionally formatted PDF dossiers with complete table of contents, bookmarks, and hyperlinked evidence.
The outcome
- auditor document retrieval and demonstration time cut
- 0 daysauditor document retrieval and demonstration time cut
- external regulatory consulting and emergency audit remediation
- $0external regulatory consulting and emergency audit remediation
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.
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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Bring us the version of this that you actually have.
Every engagement is fixed-scope and outcome-guaranteed. The scoping conversation starts with your systems, not with a template.