No medical device can be sold in Europe without CE marking. From pulse oximeters to diagnostic software, more than 106,000 product families must go through this process today, yet only 52 notified bodies are authorized to carry it out, with ever-shrinking staff. On one side, those who need more effective diagnoses and treatments have to wait longer; on the other, the companies developing them, 90% of which are startups and SMEs, rarely have an in-house regulatory structure able to handle the required documentation. Ardeevo was born to offer them exactly this expertise.

At the heart of the Rome-based startup, founded together with ZNEXT, is the meeting of the legal and technological expertise of its two founders: Giovanni Stracquadaneo, a legal expert, lecturer in healthcare innovation and serial entrepreneur, and Alessandro Santopaolo, an expert in artificial intelligence applied to healthcare and robotics.

Ardeevo guides companies through the entire regulatory pathway for medical devices, from product qualification and classification to the delivery of the technical file. The entry point is Clark, the platform's regulatory assistant, which gathers information through a guided interview and indicates the next steps as it goes.

“Today, regulatory affairs are seen as an obstacle to tackle at the end of a project, when the product is already built and every correction costs time and money. We want to bring them to the start of the journey and turn them into an advantage, because those who know the rules from day one design better and reach the market sooner. In other words, Ardeevo gives startups and SMEs the same regulatory expertise that large companies can count on, without the burden of an in-house structure.”
Giovanni Stracquadaneo, Co-founder and CEO of Ardeevo

As with every startup in its venture building program, ZNEXT supports Ardeevo as co-founder, with a €150,000 pre-seed investment, continuous operational support and access to expertise and network. The startup is the first product of the ZNEXT Founders Program and the fifth operation for ZNEXT.

“Bringing artificial intelligence into a regulated sector like the medical one means changing the way thousands of companies work, starting with SMEs and startups. They are the ones who today feel the imbalance of a sector most acutely, where certification requests are growing while the capacity to review them is shrinking. Ardeevo is exactly the kind of company we want to build. Giovanni and Alessandro have complementary skills, know the problem from the inside and have identified a market that has so far been only partially served. Our role is to give this intuition the industrial strength to become a company.”
Elena Lavezzi, CEO of ZNEXT