Sanome
Sanome is a UK-based healthtech company founded to shift healthcare from reactive to proactive care. The team develops regulated, explainable AI tools that help clinicians detect patient deterioration earlier, improving outcomes and reducing pressure on healthcare systems. Its flagship product, MEMORI, supports clinicians caring for neurological patients who are at high risk of hospital-acquired infections.
We supported Sanome in securing EU Class IIb CE certification and MHRA approval for MEMORI.
Class IIb (EU MDR)
What they needed
Sanome needed expert regulatory support to navigate the European medical device regulation landscape and secure Class IIb CE certification for MEMORI. This included defining an evidence strategy capable of demonstrating safety, quality, and clinical benefit for an AI-driven early warning system operating in a complex regulatory environment.
Who are they?
Nita Shah,
QA/RA Lead, 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.”
“The Hardian team helped us put together credible regulatory submissions – that was the first challenge they assisted us with – and they continued to help us immeasurably after, too.”
Nita Shah,
QA/RA Lead, Sanome
How we helped
We provided strategic regulatory guidance throughout the entire collaboration. Our regulatory team advised on MDR evidence requirements and helped shape a robust submission strategy, while our clinical team simultaneously pressure-tested Sanome’s clinical and technical evidence ahead of notified body review. Acting as both advisor and sounding board, we strengthened the overall submission and helped avoid unnecessary delays.
The result
MEMORI achieved Class IIb CE certification under MDR, becoming the first UK-built certified software solution designed to predict hospital-acquired infections in neurological patients in real time.