Regulatory complexity is one of the biggest bottlenecks in global MedTech innovation. Since 2015, the number of applicable compliance requirements has more than tripled, forcing R&D teams to spend up to 40% of their time on documentation and regulatory alignment. REMATIQ, a Berlin-based vertical AI startup, tackles this problem head-on. Its platform transforms complex MDR and FDA guidance into structured, machine-readable formats and creates actionable tasks for engineering teams, reducing compliance overhead by up to 90%.
The startup has secured €5.4 million in seed funding, led by Project A Ventures, with Amino Collective and HelloWorld participation. Renowned business angels have joined the round, including SaaS founder Boris Lokschin (Spryker Systems) and industry veteran Timo Fleßner.
REMATIQ plans to use the new capital to enhance its AI technology, expand its engineering team, and drive international growth across Europe and the United States. David Boutellier, Co-Founder & CEO of REMATIQ, said: “Regulatory requirements shouldn’t slow innovation — they should help accelerate it. With REMATIQ, we turn compliance from a hurdle into a competitive advantage.
Our goal is to bring life-saving MedTech solutions, from wound care to CT scanners, to patients faster. We’re grateful to our investors for believing in this vision and supporting us in reshaping the industry.”
How REMATIQ breaks down regulatory barriers
REMATIQ was established in 2023 by David Boutellier and Florian Scherer. The founders created the company to tackle the increasing intricacies of regulatory compliance within the MedTech sector, which often hinders timely patient access to life-saving innovations. They aim to streamline regulatory processes through AI, allowing MedTech firms to expedite the market launch of innovations without compromising on safety and quality standards.
Through their platform, REMATIQ aims to transform compliance from a bottleneck into a competitive advantage, ultimately empowering medical innovators to focus on delivering impactful patient solutions.
To that end, REMATIQ collaborates with leading MedTech companies worldwide. “The volume and complexity of international regulations continue to grow. We feel this every day—in development, clinical evaluation, regulatory approval, and post-market surveillance. An AI-based approach to regulatory requirements management—like the one REMATIQ offers—addresses exactly the point of highest leverage,” says Mandy Blocher, Head of PLM Digitalization & Regulatory Intelligence at the B. Braun Group.
Behind the platform: merging AI with medical compliance
The platform uses artificial intelligence to streamline compliance workflows during medical device development. It converts complex regulations, including MDR and FDA guidelines, into structured, actionable requirements and integrates them into existing systems. This approach saves up to 90% of the time typically spent on regulatory documentation and coordination, allowing engineers to focus on life-changing innovations.
Beyond simplifying compliance workflows, AI is increasingly used across MedTech for real-time device monitoring, post-market surveillance, and data-driven decision-making. REMATIQ’s platform could expand its capabilities to integrate predictive analytics or assist in drafting initial regulatory submissions based on historical data, further cementing AI’s role as an indispensable tool in MedTech development.
Moreover, REMATIQ’s platform helps address the growing talent shortage in regulatory affairs roles within MedTech companies. By automating labor-intensive tasks like documentation alignment and compliance monitoring, REMATIQ reduces the impact of this shortage while enabling faster time-to-market for innovative devices
Anton Waitz, General Partner at Project A, added, “REMATIQ is solving a mission-critical problem. While regulatory burdens are slowing many companies down, REMATIQ offers a way to dramatically increase efficiency without compromising on quality or safety. The team impressed us with deep industry expertise and a strong technology vision. We’re excited to support them on this journey.”
