What does it take to become the UK’s first certified AI tool tackling hospital-acquired infections?
Sanome has reached a landmark moment with the CE Marking of its AI-powered clinical decision support tool, MEMORI, as a Class llb medical device. This achievement represents the first UK-built certified software solution designed specifically to help clinicians prediction hospital-acquired infections in neurological patients.
Healthcare systems around the world are under immense strain, often operating in a reactive cycle of responding to illness after it has developed. Sanome, under the leadership of CEO Benedikt von Thüngen, was founded to change this paradigm and shift care from reactive to proactive. The company’s vision is to empower clinicians to anticipate risks and intervene earlier, ultimately improving outcomes for patients while easing the burden on healthcare teams.
MEMORI: a first-of-its-kind product
MEMORI is a clinical decision support (CDS) tool designed for patients with neurological injuries or conditions, who are particularly vulnerable to hospital-acquired infections. The CDS functions as an early-warning system, alerting clinicians to risks before they manifest into serious complications. While it does not replace the expertise of the clinician, MEMORI enhances decision-making by providing timely, data-driven insights. This combination of human judgment and AI assistance creates a safeguard against complications that can often be life-threatening.
Securing Class llb CE certification under the European Medical Device Regulation (MDR) makes MEMORI the first software of its kind to be approved for real-time infection prediction.
Navigating a tough regulatory landscape
Achieving CE certification under the European Medical Device Regulation (MDR) is no small feat. The MDR has significantly increased evidence and compliance requirements compared with the previous MDD framework. For Sanome, this meant demonstrating MEMORI’s safety, quality, and clinical benefit to the highest standards.
Nita Shah, QA/RA Lead at Sanome:
“Beyond their technical know-how, Hardian acted as a true partner and sounding board. We were able to openly discuss different approaches, weigh the pros and cons, and make confident decisions with their support.”
The process was complicated by the very nature of early warning systems. When interventions prevent harm from occurring, it becomes harder to prove clinical benefit, a challenge often referred to as the early warning paradox. Demonstrating how MEMORI adds value in such circumstances required a carefully considered evidence strategy.
Hardian Health’s expertise in action
To help overcome these challenges, Sanome turned to Hardian Health, whose regulatory expertise proved pivotal throughout the process. From the early stages, Hardian’s regulatory team provided strategic guidance on the type and depth of evidence required under MDR. Our granular understanding of the nuanced requirements across overlapping regulations and standards ensured that Sanome could anticipate potential obstacles before they became critical issues.
Nita Shah, QA/RA Lead at Sanome:
“Without Hardian’s guidance and steer, navigating the MDR process would have been a very difficult time for Sanome. Their detailed knowledge and ability to test our evidence before submission made a critical difference.”
As the submission progressed, Hardian played the role of both advisor and sounding board. We pressure-tested Sanome’s evidence internally, providing detailed feedback before it was submitted to the notified body. This not only strengthened the overall submission but also helped avoid unnecessary delays that could have resulted from regulator pushback.
Lessons for the wider industry
From the outset, Sanome has embraced a culture where quality and compliance are seen as enablers of innovation rather than obstacles. This proactive mindset has helped the company avoid the common pitfalls faced by startups that treat regulation as an afterthought. The key lesson for other digital health and AI-driven medical device companies is simple: regulatory planning must begin early.
By partnering with Hardian Health, Sanome successfully navigated one of the most complex regulatory pathways in the sector, setting a benchmark for how startups can integrate quality and compliance into their mission. Early, strategic regulatory planning, supported by the right expertise, can transform ambitious ideas into approved products that deliver real-world impact.
If your company is navigating complex regulatory pathways for your AI medical device, get in touch with Hardian Health to see how our expertise can support your journey.
