Partnering with REMATIQ: Revolutionising Compliance in MedTech

In our latest investment spotlight, we explore how Rematiq is enabling MedTech professionals to focus on what matters most – accelerating the development of life-saving technologies and bringing solutions to patients faster.

Over the years, we’ve witnessed countless teams struggle with compliance, viewing it as an unavoidable and overwhelming burden. This mindset has led to projects experiencing significant delays or being abandoned before they begin. While some progress has been made in streamlining these processes, the true potential of automation in complex, highly regulated industries like life sciences and manufacturing remains largely untapped.

The challenge is intensifying as the volume of requirements in regulated industries continues to grow exponentially. Medical technology provides a stark example: regulations have tripled since 2015 in both Europe and the US. Today, a single company may need to navigate between 1500 and 3000 regulations, with over 300 regulatory updates occurring annually for existing products. This avalanche of information, scattered across numerous systems and documents, typically falls to teams to manage manually. As a result, REMATIQ’s market research reveals that R&D engineers spend a staggering 40% of their time on regulatory paperwork instead of innovation, significantly hampering product development cycles.

Yet we firmly believe that an exceptional compliance system can transform from a necessary evil into a strategic advantage. Organisations with superior compliance capabilities can expand into new markets with greater speed and confidence while simultaneously shortening R&D timelines. This opportunity to fundamentally reimagine compliance as a competitive edge is precisely what drew us to REMATIQ.

REMATIQ is building an AI-powered platform that is transforming how medical device companies navigate this complex landscape. By analysing and integrating regulatory requirements into the product development process in real-time, they’re slashing documentation efforts by 90%. Their platform translates complex U.S. Food and Drug Administration (FDA) and Medical Device Regulation (MDR) guidelines into clear, actionable requirements and embeds them directly into existing company workflows. What’s particularly exciting is seeing REMATIQ already partnering with some of the largest MedTech manufacturers, helping them speed up market entry and ensure compliance from day one.

The vision, however, extends far beyond medical devices. Across all regulated industries, bringing out mission-critical innovation is constrained by ever-increasing and complex regulation. This trend is accelerated by deglobalisation, technological progress, and cultural shifts toward priorities like sustainability. These factors prompt governments to create new laws and regulations at an unprecedented pace. While these requirements will continue to be issued in PDF format for the foreseeable future, the emergence of Large Language Models has dramatically transformed our ability to collect, process, simplify, and implement them.

This technological shift is exactly where REMATIQ is focused: building a comprehensive interface between companies and the regulatory world by deeply integrating regulatory data into their customers’ critical workflows.

The Superpower Team Tackling a Complex Space

When we first met David and Florian, their expertise, alongside their killer instinct, drive, and ambition stood out. David led cross-functional teams at Kaia Health and was responsible for approvals for multiple medical devices in both Europe and the US. He’s lived the pain points first-hand. Having built AI products for over eight years, Florian brings the technical vision needed to solve these complex challenges. But beyond their impressive backgrounds, their core belief – that regulation is essential but should not be a barrier to medical innovation – resonated deeply with us and underpins their entire approach.

Hearing Mandy Blocher, Head of PLM Digitalisation & Regulatory Intelligence at B. Braun, say that solutions like REMATIQ’s AI-based approach to regulatory requirements “start precisely where the leverage is greatest” confirmed what we already believed: this solution addresses one of the industry’s most pressing challenges. This goes beyond making compliance easier; it’s about freeing talented individuals to focus on what they do best: creating life-changing innovations.

Why REMATIQ, Why Now

We’ve reached a critical technological inflection point. For the first time, AI systems are capable of handling vast volumes of unstructured information with the precision required in zero-error-tolerance industries. Now, AI is getting to a state where, with the right guardrails one can reach almost 100% accuracy. Even with a human-in-the-loop to check the output, this creates significant time savings for teams. As the underlying AI models continue to evolve, so too will REMATIQ’s solution.

This timing couldn’t be better for the MedTech sector, where the largest manufacturers invest billions in R&D each year to bring vital products – from CT scanners to surgical systems – to market. For these companies, speed to market has a direct impact on both commercial success and patient outcomes.

We’re proud to be leading REMATIQ’s €5.4 million Seed round, alongside renowned business angels including founders Boris Lokschin (Spryker) and David Schneider (Qualifyze) and industry veteran Timo Fleßner from Bayer. With this funding, REMATIQ will continue investing in its AI technology, grow its engineering team, and expand internationally across Europe and the US.

The impact goes far beyond a single company, though. It will help accelerate the development of life-saving technologies across the entire industry and bring solutions to patients faster.