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Join us on our mission to get ten times more life-changing innovations to patients: faster, safer, and more affordably.

Join the Guideways Explorers Community and be the first to get access

Guideways Explorers is an on-invite early access community for medtech innovators who want to actively shape how AI can accelerate regulatory approval and compliance

Guideways Explorers gives teams early access to our full suite of AI agents and unique benefits

Guideways Explorers receive early access to Guideways before our first commercial release of the platform and will continue to receive early access to new capabilities as the platform expands and new regulatory areas are added.

FDA Sherpa

Your starting point for classification, predicates, pathways, guidances, standards and controls. Sherpa turns a plain-language device description into an underpinned regulatory strategy.

FDA Reviewer

FDA Reviewer helps you find gaps and inconsistencies in regulatory submissions before regulators do, reducing the risk of delays, questions and rework.

FDA Researcher

FDA Researcher delivers deep, evidence-backed regulatory answers without the need to manually search and cross-reference dozens of documents.

Early Access

Early access to the Guideways platform features before public availability

Exclusive Events

Invitations to expert sessions and community events

Influence

A direct channel to influence future releases and features

Expanded Usage

Expanded usage allocation, including 4 additional devices across FDA Sherpa, FDA Reviewer and FDA Researcher, and 20 user seats