Utrecht-based startup Guideways has secured over €1 million in pre-seed funding to develop its AI platform aimed at streamlining compliance and approval processes for medical technology companies.

Target Information

Guideways, a startup based in Utrecht, has successfully raised over €1 million in pre-seed funding to advance its AI platform designed for medical technology companies. The funding round was led by Healthy.Capital and Rising Star Venture Partners. Founded in 2024 by Alexander Habermeier and Sander Denissen, Guideways leverages their combined experience of over 30 years in the medical technology sector to address significant challenges within the industry.

The company focuses on addressing complex approval and compliance processes that consume up to 75% of development costs and delay market entry by 31 to 66 months. By utilizing agentic AI—intelligent agents capable of independent reasoning at an expert level—Guideways aims to automate critical tasks such as regulatory advice, document verification, and research activities. This innovation is expected to accelerate the delivery of medtech innovations to patients by months or even years.

Industry Overview

The medical technology industry in the Netherlands is rapidly evolving, with a strong emphasis on innovation and efficiency. With a robust ecosystem of startups and established companies, the industry faces the dual challenge