As compliance eats 75% of MedTech budgets, Utrecht’s Guideways raises over €1 million to speed FDA approvals
Guideways, the Dutch AI company helping MedTech innovators navigate regulatory and compliance complexity, has raised over €1 million in pre-Seed financing according to a source close to the round.
The investment came from HealthTech funds Healthy.Capital and Rising Star Venture Partners and will be used to launch and scale Guideways’ agentic AI platform, built to help medical device companies achieve regulatory approval and bring lifesaving technologies to patients years faster.
Alexander Habermeier, co-founder of Guideways: “At Guideways, our mission is simple: get 10 times more life-changing innovations to patients, faster and even safer. We are thrilled to have successfully closed our pre-Seed funding round. This investment will accelerate the development of our groundbreaking AI platform and empower MedTech innovators to deliver their life-saving new technologies to patients months, or even years, sooner.”
In context: This pre-Seed funding Guideways aligns with a broader 2025 trend across Europe where AI and automation are being applied to regulatory and compliance challenges in MedTech.
In April 2025, REMATIQ (Berlin) raised €5.4 million to advance its AI-native platform for automated product compliance, highlighting investor confidence in tools that streamline regulatory workflows. Earlier in the year, Mulder secured €597k in pre-Seed funding to develop a medical-device traceability platform.
While both REMATIQ and Mulder operate in adjacent compliance and traceability niches, Guideways stands out for its focus on agentic AI built specifically for regulatory approval processes – initially targeting U.S. FDA pathways before expanding to European MDR frameworks.
Douwe Jippes, Co-founder and Managing partner at Healthy.Capital: “The team at Guideways has a deep, personal understanding of the problem they are solving. They help companies to bring innovations to market faster and more successfully by significantly reducing the approval time and costs, fundamentally changing how medical devices are brought to market. This makes healthcare innovation more accessible and efficient, which perfectly aligns with our mission at Healthy.Capital to make healthcare affordable and accessible.”
Founded in 2024, Guideways develops AI agents that “cut through regulatory approval, compliance, and reimbursement complexity” for MedTech innovators.
With more than 37 years of combined MedTech experience, the founding team has seen first-hand how regulatory hurdles derail promising innovations. Guideways’ platform aims to automate the most time-consuming parts of compliance through a suite of specialised AI agents, focused initially on the U.S. FDA approval process:
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FDA Sherpa: guides teams from a concept description to a detailed approval strategy, identifying the correct classification, pathway, requirements, and standards.
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FDA Reviewer: performs in-depth checks of regulatory submissions, reviewing hundreds of documents for compliance and suggesting fixes.
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FDA Researcher: enables natural-language exploration of a knowledge base of more than 150,000 reference documents, combining information intelligently to answer complex queries.
Saskia ten Siethoff, QA/RA Specialist, Flux Robotics added: “Using Guideways’ FDA Sherpa helped us quickly define our intended use and map out the right FDA pathway for our next-generation vascular surgery robot. It not only saved time but also explained the reasoning behind its recommendations; something that really built confidence to navigate complex regulations.”
Every year, tens of thousands of promising medical technologies are slowed down by the complexity of regulation, quality and reimbursement. According to data provided by the company, processes today consume up to 75% of MedTech development costs and can delay market entry by 31 to 66 months.
Behind those delays are patients waiting for better care.
Martijn van de Giessen, CEO, Secuped: “As a MedTech company, regulatory requirements have an enormous impact on our strategy and road to market. Guideways made it easy and accessible for us to quickly assess where we stand and how to proceed.”
The new funding will support commercial launch activities, ongoing platform development, and expansion toward European MDR and reimbursement frameworks in 2026.
Benjamin Sieters, Investment Director at Rising Star Venture Partners added: “Guideways is a prime example of a company with the potential for fast and massive impact. By addressing barriers within the innovation pipeline, the company empowers health technology innovators to succeed and bring their solutions faster and more cost-effectively to a global market.
“We have seen first-hand how Guideways’ platform can reliably fast-track complicated and expensive steps in the critical route to regulatory approval, compliance and reimbursement. We are proud to back their mission to accelerate the availability of groundbreaking medical technologies.“
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