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 know-how, develop its engineering workforce, and drive development throughout Europe and the U.S.
The spherical is led by Venture A Ventures, with participation from Amino Collective and HelloWorld, and complemented by enterprise angels equivalent to SaaS founder Boris Lokschin (Spryker Methods) and trade 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 carry life-saving MedTech options – from wound care to CT scanners – to sufferers sooner. We’re grateful to our traders for believing on this imaginative and prescient and supporting us in reshaping the trade.”
REMATIQ was based in 2023 by David Boutellier and Florian Scherer. They consider that regulatory necessities are important—however they need to by no means maintain again innovation. With REMATIQ, they give the impression of being to assist MedTech firms scale back regulatory complexity with out sacrificing high quality or security.
The platform makes use of AI to simplify compliance workflows throughout medical system growth. It interprets laws – like MDR and FDA – into structured, actionable necessities and integrates them into firms’ present methods. This reportedly saves as much as 90% of the time usually required for regulatory documentation and coordination – releasing up engineers to concentrate on doubtlessly life-changing improvements.
In keeping with REMATIQ, regulatory necessities are among the many greatest challenges within the MedTech trade: greater than 40% of R&D groups’ time is spent on guide regulatory duties – time that may very well be used for innovation.
REMATIQ’s AI-powered platform analyses world regulatory paperwork and supplies actionable necessities. These are built-in instantly into growth and high quality processes, reportedly lowering documentation efforts by as much as 90% and considerably decreasing the chance of non-compliance.
“The amount and complexity of worldwide laws proceed to develop. We really feel this each day – in growth, scientific analysis, regulatory approval, and post-market surveillance. An AI-based method to regulatory necessities administration – just like the one REMATIQ provides – 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 know-how, develop its engineering workforce, and drive worldwide development throughout Europe and the US.
Anton Waitz, Common Associate at Venture A, provides: “REMATIQ is fixing a mission-critical downside. Whereas regulatory burdens are slowing many firms down, REMATIQ provides a option to dramatically enhance effectivity – with out compromising on high quality or security. The workforce impressed us with deep trade experience and a powerful know-how imaginative and prescient. We’re excited to help them on this journey.“
