healthcare
Quality & Compliance
representative

Global Medical Device Portfolio Compliance & EU MDR / FDA Regulation Updates

A global medical technology manufacturer with a portfolio of 450 class II and class III cardiovascular and orthopedic devices marketed across 35 countries.

Runs onParivart

regulatory change detection and impact analysis time cut: 6 weeksregulatory change detection and impact analysis time cut
reduced regulatory consulting and contractor spend: $480,000reduced regulatory consulting and contractor spend

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

Regulatory affairs teams monitored dozens of global health authority websites manually (FDA, EMA, NMPA, PMDA), missing critical guidance updates.
A new EU MDR clinical evaluation guidance revision required updates to 180 device Technical Files, but identifying affected product families took 6 weeks.
Delayed submission of updated regulatory filings risked product market withdrawal in key European territories.

The run · 5 operational steps

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

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Global Health Authority Feed Ingestion

Parivart ingests and indexes real time regulatory notices, guidance documents, and safety bulletins from over 40 global regulatory agencies.

Input Signal:

Real-time operational telemetry & queue

Reasoning Pattern:

MCP grounded vector inference

Governance Gate:

Policy constrained with audit write-back

Verified Business Outcomes

Regulatory change detection and impact analysis time cut from 6 weeks to 2 hours.
Zero product market withdrawals or license suspensions across all 35 global market jurisdictions.
Reduced regulatory consulting and contractor spend by $480,000 annually.

Capabilities this relies on

document intelligence
system connectors
risk scoring
policy compliance
alert routing
evidence audit trail

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