healthcare
Quality & Compliance
representative

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.

Runs onTatvam

risk management file compilation time reduced: 4 monthsrisk management file compilation time reduced
compliance achieved during FDA 510(k) and ISO 14971 notified: 100%compliance achieved during FDA 510(k) and ISO 14971 notified

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

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.

The run · 5 operational steps

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

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Digital DFMEA Control Room Workspace

Tatvam unifies system architecture, electrical schematics, firmware modules, and clinical hazards into one structured digital workspace.

Input Signal:

Real-time operational telemetry & queue

Reasoning Pattern:

MCP grounded vector inference

Governance Gate:

Policy constrained with audit write-back

Verified Business Outcomes

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.

Capabilities this relies on

document intelligence
risk scoring
generative design
evidence audit trail
policy compliance
human approval

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