Sherpa

From a plain-language device description to an underpinned approval strategy

FDA

MDR / IVDR

Sherpa turns your device description into a detailed approval strategy: classification options, applicable pathways, potential predicates, and mapped requirements. You get a comprehensive and underpined overview of requirements that apply specificlly to your device, without days of manual research, and with a transparent reasoning for each conclusion.

You start with a plain-language description of the device and Sherpa expertly guides you to an underpinned strategy.

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Concept to analysis flow

From a simple product description to a structured regulatory approval analysis in one workflow

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Structured intelligence

Uses a curated, structured set of more than 1,6M regulatory documents

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Multi agent reasoning

Specialized agents follow prerequisite logic, run evidence searches, and define a coherent strategy

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Evidence backed output

Insights are supported by reference sources and transparent reasoning that teams can review

Check Out The Pathway Specific Features

FDA Sherpa

MDR Sherpa

IVDR Sherpa

Sherpa enables earlier alignment across functions and more confident go-to-market planning.

The output is a detailed, evidence-backed overview that your team can access directly in the platform. Anyone in R&D, Regulatory, Quality, or Clinical can review it, create a new variation, and share it with the team.

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