Medical Device Design Risk Analysis & ISO 14971 Compliance
A medical device company developing an automated wearable insulin infusion pump and continuous glucose monitoring (CGM) system seeking FDA 510(k) clearance and CE mark certification.
Run on Tatvam · Design Risk & FMEA
The challenge
Design Failure Mode and Effects Analysis (DFMEA) was managed across massive, disconnected Excel spreadsheets with over 2,500 rows.
Cross functional engineering teams (mechanics, firmware, human factors) worked in silos, leading to unaligned risk scores and missed hazard intersections.
Preparing audit ready risk management files compliant with ISO 14971:2019 and FDA 21 CFR 820.30 took 4 months of manual document collation.
How Tatvam solves it
Digital DFMEA Control Room Workspace
Tatvam unifies system architecture, electrical schematics, firmware modules, and clinical hazards into one structured digital workspace.
Standardized ISO 14971 Risk Scoring
Enforces standardized Severity, Probability of Occurrence, and Detection criteria with automated Risk Priority Number (RPN) calculations.
Multi Disciplinary Team Collaboration
Enables mechanical, software, and clinical risk engineers to collaborate concurrently on shared hazard tables with role based approvals.
Automated Risk Control Verification Linking
Binds every identified failure mode to specific risk mitigation controls and design verification test protocols.
One Click Regulatory Risk Dossier Generation
Generates certified, fully formatted Risk Management Reports (RMR) and Hazard Traceability Matrices for FDA submissions.
The outcome
- risk management file compilation time reduced
- 0 monthsrisk management file compilation time reduced
- compliance achieved during FDA 510(k) and ISO 14971 notified
- 0%compliance achieved during FDA 510(k) and ISO 14971 notified
Risk management file compilation time reduced from 4 months to 3 days.
100% compliance achieved during FDA 510(k) and ISO 14971 notified body audits with zero findings.
Eliminated spreadsheet version conflicts and data loss completely across engineering teams.
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.