REMATIQ Raises €5.4 Million To Improve MedTech’s AI Compliance

The AI-native platform for MedTech’s automated product compliance, REMATIQ, based in Berlin, has raised €5.4 million in a seed fundraising round to advance its AI technology, strengthen its engineering staff, and spur expansion in both Europe and the US.

Project A Ventures is leading the round, with Amino Collective and HelloWorld joining in. Business angels like Timo Fleßner, an industry veteran, and SaaS founder Boris Lokschin (Spryker Systems) are also involved.

“Regulations should not hinder innovation; rather, they should promote it. According to David Boutellier, co-founder and CEO of REMATIQ, “We transform compliance from a barrier into a competitive advantage with REMATIQ.” Our objective is to expedite the delivery of life-saving MedTech solutions to patients, ranging from CT scanners to wound care. We appreciate our investors’ support and belief in our mission as we work to transform the industry.

In 2023, David Boutellier and Florian Scherer launched REMATIQ. They contend that while regulations are necessary, innovation should never be impeded by them. They hope that REMATIQ will assist MedTech companies in simplifying regulations without compromising safety or quality.

The software streamlines compliance processes during the creation of medical devices by utilizing AI. It converts rules, such as the FDA and MDR, into organized, implementable specifications and incorporates them into businesses’ current processes. According to reports, this frees up engineers to concentrate on potentially game-changing inventions by saving up to 90% of the time normally needed for regulatory documentation and collaboration.

One of the largest obstacles facing the MedTech sector, according to REMATIQ, is regulatory regulations. Over 40% of R&D teams’ time is devoted to manual regulatory tasks, which takes away from time that should be spent on innovation.

The AI-powered platform from REMATIQ evaluates international regulatory papers and offers requirements that may be put into practice. These are directly included into quality and development processes, which has been shown to drastically reduce the risk of non-compliance and reduce documentation efforts by up to 90%.

International regulations are getting more and more complicated. In development, clinical assessment, regulatory approval, and post-market surveillance, we experience this on a daily basis. The point of greatest leverage is precisely addressed by an AI-based approach to regulatory requirements management, such as that provided by REMATIQ, according to Mandy Blocher, Head of PLM Digitalization & Regulatory Intelligence at the B. Braun Group.

With the additional funding, REMATIQ intends to advance its AI technology, boost its engineering staff, and promote global expansion in both Europe and the US.

Anton Waitz, General Partner at Project A, adds: “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.“