Introducing the Guideways Explorers early access community

Early access to the Guideways platform for medtech innovators

Regulatory and compliance complexity remains one of the biggest barriers to bringing medical innovation to patients. While science and technology continue to move fast, regulatory approval processes often do not. As a result, even the most promising and life-changing medical technologies can be delayed for months or years. Guideways was built to change this.
As we move toward the commercial launch of the Guideways platform, we are opening Guideways Explorers. This is an on-invite early access community for medtech innovators who want to actively shape how AI can accelerate regulatory approval and compliance in the context of their own medical devices and submissions.

Guideways Explorers connects medtech teams who share a common goal: accelerating safe and effective medical innovation by breaking through the complexity of regulatory approval & compliance with AI.

What is Guideways Explorers?

Guideways Explorers gives selected teams early access to the Guideways platform itself, including FDA Sherpa, FDA Reviewer and FDA Researcher. This is the first commercial release of the platform, offered ahead of broader availability. The Explorers community will continue beyond the initial launch phase. Explorers will continue to receive early access to new capabilities as the platform expands and new regulatory areas are added.

Why join Guideways Explorers?

Bringing medical innovation to patients faster depends on making the right regulatory decisions early. Clear insight into pathways and requirements reduces uncertainty, limits rework and builds confidence as development progresses.
Guideways Explorers offers selected members early access to the Guideways platform, so they can use AI built for medtech regulation in their ongoing regulatory work before the public launch.

This early access is for teams in medtech & digital health SMEs that want to:

• Gain earlier clarity on regulatory pathways and requirements
• Reduce uncertainty and rework later in development
• Start working with AI built specifically for medtech regulation
• Share feedback based on real-world use of the platform

Guideways Explorers receive the following benefits with their subscription:

• Early access to the Guideways platform features before public availability
• Invitations to expert sessions and community events
• Expanded usage allocation with one additional device across FDA Sherpa, FDA Reviewer and FDA Researcher, and five user seats
• A direct channel to influence future releases and features

Request access

Guideways Explorers brings together medtech innovators who are pushing the boundaries of how regulatory work can be done. If you are working on innovative medical technology and want early access to the Guideways platform, you can request an invitation below.

Request access to Guideways Explorers

Join us in getting life-changing innovations to patients faster, safer and more affordably.