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#UnderTheBridge is a brand new initiative that allows for greater knowledge-based connectivity in our member community which holds unique expertise and experience when it comes to entering the US-market.
Cerenion Oy is the first MedTech Bridge member to host Under The Bridge - a knowledge sharing session for our members, by our members. Ilkka Juuso, Co-Founder & COO at Cerenion shared his experience and expertise on the topic: Building an ISO13485 ready QMS system for an AI-based SaMD (Software as a Medical Device) – and the challenges to be prepared for.
“It was my absolute pleasure to talk to other MTB members and hopefully share some actionable insight on the standard. I am always up for sharing and learning, and this event achieved both in spades." - Ilkka Juuso
Cerenion holds unique expertise as it just received a CE Mark of approval for their C-Trend software library providing qEEG analysis (C-Trend Index, BSR, aEEG, and ADR) for EEG data inputs.
“ISO 13485 quality management is something that will now touch every medical device company in Europe with the transition to MDR this spring. The audience for it is greater than ever, and the interest in it goes to the core of operations in the field. Luckily it is a very good standard." - Ilkka Juuso
🚀 Are you a member of #MedTechBride - and do you want to share your experiences and expertise while facilitating dialogue with other Nordic MedTech Companies? Reach out to the MedTech Bridge Team.
Cerenion provide the AI tools for the analysis of brain function in intensive care. Read more about the Next-Generation Brain Monitoring Company.