We work alongside Digital Health companies and Deployers in complying jointly with the AI Act and the Medical Device Regulation (MDR) as they apply to medical devices and software based on artificial intelligence.
The service starts from the correct qualification of the product — as a medical device and, at the same time, as an AI system that is often high-risk — to manage the two conformity assessment procedures in a coordinated way and avoid duplication. We assist the Client in aligning the technical and clinical documentation, defining human oversight and risk management measures and obtaining the CE marking of the system. We also handle the contractual arrangements with developers, suppliers and healthcare facilities, allocating liability and obligations along the chain.
We aim to provide strategic advice combining regulatory, healthcare and technology expertise, supporting the product from design through to placing on the market and post-market surveillance.