Artificial Intelligence in Medical Devices (Regulation 2024/1689 and ISO 42001)

The integration of Artificial Intelligence into Medical Devices (AI-MD) represents one of the most dynamic frontiers in recent years, requiring highly specialized and up-to-date expertise. Our team provides regulatory consulting to support companies in the development, certification, and risk management of AI-based medical devices.

• Supporto per la conformità al Regolamento Europeo 2024/1689 (AI Act):  Regulation 2024/1689 establishes a harmonized legal framework for Artificial Intelligence within the European Union. For medical devices incorporating AI, the AI Act complements the MDR (Regulation 2017/745). We offer consulting services for:
  • AI risk assessment;
  • Integration with MDR requirements;
  • Development of AI governance strategies.
• Implementation of ISO/IEC 42001: ISO/IEC 42001 is the international standard that defines requirements for Artificial Intelligence Management Systems (AI MS). It is based on a risk management approach, helping organizations identify and control potential impacts of AI systems. For medical device manufacturers, this standard must be integrated with the EU MDR (2017/745) and the AI Act (Regulation 2024/1689).

   

Why FTR ADVISOR? Because we are expert, multidisciplinary partners who stay up to date with the evolving regulatory landscape of AI in medical devices.