Navigating medical regulations has become one of the biggest hurdles for MedTech innovators worldwide. Since 2015, the number of compliance requirements has more than tripled, often consuming up to 40% of R&D teams’ time. That’s the challenge Berlin-based startup REMATIQ is aiming to solve using artificial intelligence.
Founded in 2023 by David Boutellier and Florian Scherer, REMATIQ is turning compliance from a burdensome task into a growth enabler. Its AI-driven platform converts complex medical regulations—like MDR and FDA guidelines—into structured, machine-readable tasks. The goal? To simplify compliance workflows and slash regulatory overhead by as much as 90%.
Now, the company has raised €5.4 million in seed funding. The round was led by Project A Ventures, with participation from Amino Collective and HelloWorld. Notable angel investors also joined, including Spryker co-founder Boris Lokschin and MedTech veteran Timo Fleßner.
Accelerating MedTech Innovation by Reducing Regulatory Pain
REMATIQ’s platform is designed for MedTech teams bogged down by the growing complexity of global compliance standards. The startup’s AI system translates dense regulatory texts into clear, actionable items. This empowers engineering teams to focus more on product innovation and less on documentation.
“We believe regulations should speed up innovation—not slow it down,” said David Boutellier, REMATIQ’s Co-Founder and CEO. “With REMATIQ, compliance becomes a strategic advantage rather than a bottleneck. Our mission is to help MedTech teams bring life-saving products, from wound care to CT scanners, to patients faster.”
With this new funding, REMATIQ plans to boost its AI capabilities, hire top engineering talent, and expand operations across Europe and the U.S.
How REMATIQ is Transforming Regulatory Compliance
The REMATIQ platform doesn’t just parse documents—it transforms the entire compliance process. It breaks down regulatory requirements into detailed tasks and integrates seamlessly with existing development workflows. This cuts down hours spent on alignment and coordination, freeing up time for actual medical innovation.
This tech is already gaining traction. REMATIQ partners with leading MedTech firms who face growing regulatory pressures in clinical evaluation, approval, and post-market monitoring. Mandy Blocher, Head of PLM Digitalization & Regulatory Intelligence at B. Braun Group, explained: “The increasing complexity of global regulations impacts every phase of MedTech development. An AI-based system like REMATIQ gives us the leverage we need to manage it effectively.”
Solving a Talent Crisis in Regulatory Affairs
Regulatory affairs professionals are in short supply—a growing concern for MedTech companies worldwide. REMATIQ helps fill that gap by automating time-consuming tasks such as document matching, version tracking, and compliance monitoring. This automation not only reduces hiring pressure but also speeds up the path to market for new medical devices.
Beyond its core functionality, the platform’s AI could soon power predictive analytics and auto-generate draft submissions using historical data—unlocking even more value for regulatory teams.
Investors See Huge Potential
For Project A Ventures, REMATIQ stood out for its vision and market relevance. “They’re solving a critical problem,” said General Partner Anton Waitz. “Most companies are stuck in regulatory quicksand. REMATIQ changes that—boosting efficiency without sacrificing safety or quality. The team has both deep domain expertise and a compelling tech roadmap. We’re proud to support them.”
