Berlin-based REMATIQ, an AI-native platform for automated product compliance in MedTech, has raised €5.4 million in a Seed funding spherical to develop its AI expertise, develop its engineering staff, and drive development throughout Europe and the U.S.
The spherical is led by Undertaking A Ventures, with participation from Amino Collective and HelloWorld, and complemented by enterprise angels resembling SaaS founder Boris Lokschin (Spryker Methods) and business veteran Timo Fleßner.
“Regulatory necessities shouldn’t decelerate innovation – they need to assist speed up it. With REMATIQ, we flip compliance from a hurdle right into a aggressive benefit,” says David Boutellier, Co-founder & CEO of REMATIQ. “Our objective is to convey life-saving MedTech options – from wound care to CT scanners – to sufferers quicker. We’re grateful to our buyers for believing on this imaginative and prescient and supporting us in reshaping the business.”
REMATIQ was based in 2023 by David Boutellier and Florian Scherer. They imagine that regulatory necessities are important—however they need to by no means maintain again innovation. With REMATIQ, they appear to assist MedTech corporations cut back regulatory complexity with out sacrificing high quality or security.
The platform makes use of AI to simplify compliance workflows throughout medical machine improvement. It interprets rules – like MDR and FDA – into structured, actionable necessities and integrates them into corporations’ present techniques. This reportedly saves as much as 90% of the time usually required for regulatory documentation and coordination – liberating up engineers to give attention to doubtlessly life-changing improvements.
In keeping with REMATIQ, regulatory necessities are among the many greatest challenges within the MedTech business: greater than 40% of R&D groups’ time is spent on handbook regulatory duties – time that might be used for innovation.
REMATIQ’s AI-powered platform analyses international regulatory paperwork and offers actionable necessities. These are built-in straight into improvement and high quality processes, reportedly decreasing documentation efforts by as much as 90% and considerably reducing the danger of non-compliance.
“The quantity and complexity of worldwide rules proceed to develop. We really feel this day by day – in improvement, medical analysis, regulatory approval, and post-market surveillance. An AI-based strategy to regulatory necessities administration – just like the one REMATIQ gives – addresses precisely the purpose of highest leverage,” says Mandy Blocher, Head of PLM Digitalization & Regulatory Intelligence on the B. Braun Group.
REMATIQ plans to make use of the brand new capital to additional develop its AI expertise, develop its engineering staff, and drive worldwide development throughout Europe and the US.
Anton Waitz, Normal Associate at Undertaking A, provides: “REMATIQ is fixing a mission-critical drawback. Whereas regulatory burdens are slowing many corporations down, REMATIQ gives a approach to dramatically improve effectivity – with out compromising on high quality or security. The staff impressed us with deep business experience and a robust expertise imaginative and prescient. We’re excited to assist them on this journey.“
