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 crew, 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 resembling SaaS founder Boris Lokschin (Spryker Programs) 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 aim is to convey life-saving MedTech options – from wound care to CT scanners – to sufferers sooner. We’re grateful to our buyers 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’ current programs. This reportedly saves as much as 90% of the time usually required for regulatory documentation and coordination – liberating up engineers to concentrate on probably life-changing improvements.
In response to REMATIQ, regulatory necessities are among the many largest challenges within the MedTech trade: greater than 40% of R&D groups’ time is spent on guide regulatory duties – time that might be used for innovation.
REMATIQ’s AI-powered platform analyses international regulatory paperwork and supplies actionable necessities. These are built-in instantly into growth and high quality processes, reportedly decreasing documentation efforts by as much as 90% and considerably reducing the chance of non-compliance.
“The amount and complexity of worldwide laws proceed to develop. We really feel this daily – in growth, medical analysis, regulatory approval, and post-market surveillance. An AI-based strategy to regulatory necessities administration – just like the one REMATIQ affords – 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 crew, and drive worldwide development throughout Europe and the US.
Anton Waitz, Common Companion at Venture A, provides: “REMATIQ is fixing a mission-critical downside. Whereas regulatory burdens are slowing many firms down, REMATIQ affords a solution to dramatically enhance effectivity – with out compromising on high quality or security. The crew impressed us with deep trade experience and a powerful know-how imaginative and prescient. We’re excited to assist them on this journey.“
