About Guideways
Regulatory, compliance and reimbursement work is essential, but much of it is repetitive and evidence-heavy: reading through extensive regulations and reimbursement policies, assessing classification and pathways for similar devices, and checking documentation against mapped requirements. It slows projects, ties up scarce experts, and delays critical product decisions.
Guideways automates this analysis so your team can focus on developing and improving life-changing medical technologies.
Our goal is to dramatically accelerate regulatory, compliance and reimbursement processes using AI agents that break through the complexity with deep research, expert-level analysis, and structured checks while you stay in control of decisions and communication with authorities.
Our mission
Our mission is to get ten times more life-changing medical innovations to patients faster, safer, and more affordably.
Behind every delayed regulatory decision are patients waiting for better care. By removing unnecessary friction from regulatory, compliance and reimbursement work, Guideways helps medtech teams make earlier, better-informed decisions while maintaining full rigor and accountability.
We believe regulatory, compliance and reimbursement excellence should accelerate innovation, not slow it down.
Founders
We are medtech innovators who have taken new concepts from sketch to market across imaging, in-body devices, surgical robotics, and ML/AI tech stacks. That includes full regulatory lifecycles from first concept to clearance and post-market work.
After experiencing how slow and fragmented current healthcare technology innovation processes are, we set out to accelerate how safe and effective innovations reach patients, without relaxing regulatory standards.
Alexander Habermeier
CEO
Sander Denissen
CTO
Investors
