FDA
Sherpa
From a plain-language device description to an underpinned approval strategy
FDA 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 FDA Sherpa expertly guides you to an underpinned strategy
Key Features
Concept to analysis flow
From a simple product description to a structured regulatory approval analysis in one workflow
Structured intelligence
Uses a curated, structured set of more than 150,000 regulatory documents
Multi agent reasoning
Specialized agents follow prerequisite logic, run evidence searches, and define a coherent strategy
Evidence backed output
Insights are supported by reference sources and transparent reasoning that teams can review
FDA 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.
Who can benefit from Guideways.ai?
Startups & Scaleups
Designed to give young companies early regulatory clarity without building a full in-house function.
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Expert insight, no headcount
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Early pathway clarity
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Stronger stakeholder credibility
MedTech Companies
Built to support internal regulatory teams when speed and capacity matter most.
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Scalable capacity support
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Faster initial input
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Clearer early guidance
Regulatory Consultants
Helps consultants work faster and serve more clients without stretching teams.
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Reduced research time
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Higher client throughput
Each group follows a different path but faces the same bottlenecks. Guideways helps them all move forward.