MedSafe

About

MedSafe is a research project aimed at developing an AI-based assistance system for the regulatory safety of medical devices. Its goal is to support SMEs and research institutions in efficiently implementing complex regulatory requirements and partially automating the creation of safety evidence. The project lays the foundation for bringing innovative medical technologies to market faster, more safely, and with greater resource efficiency.

Opportunity

The development of medical devices is subject to strict regulatory requirements, particularly in the area of risk management. These requirements demand specialized expertise, extensive documentation, and significant human and financial resources.

Small and medium-sized enterprises (SMEs) in particular face major challenges: limited budgets, constrained personnel capacities, and lengthy approval processes significantly hinder market entry. At the same time, the complexity of modern medical devices—such as software-intensive systems or AI-based applications—is continuously increasing.

There is a lack of scalable, transparent, and structured solutions that guide companies through regulatory processes and efficiently support the creation of safety-related evidence.

Solution/Product description

MedSafe follows a model-based, AI-supported assistance approach for the structured implementation of regulatory requirements. At its core is the development of an intelligent tool that guides users through relevant questions and systematically supports the creation of key safety artifacts.

The system makes regulatory requirements understandable, identifies project-specific needs, and translates them into concrete development processes. Safety-related documentation is prepared in a structured manner along the development lifecycle and partially generated automatically.

A particular focus is placed on real-world development scenarios, including complex medical devices with multiple hardware and software components, as well as AI-based systems. Risks, dependencies, and safety arguments can thus be consistently captured, analyzed, and documented in a transparent and traceable manner.

Why Us

MedSafe combines model-based methodology with AI-driven assistance to specifically address the increasing regulatory complexity of modern medical devices. This approach enables, for the first time, the structured, transparent, and partially automated generation of safety evidence throughout the entire development process.

By consistently addressing the needs of SMEs and closely integrating regulatory expertise, technological innovation, and practical application, MedSafe provides a scalable solution for accelerating the safe and efficient translation of medical technology innovations into the market.

MedSafe is a joint research project involving several Fraunhofer Institutes.

Participating institutions:

• Fraunhofer Research Institution for Individualized Medical Technolody and Engineering IMTE
  The Fraunhofer IMTE complements the project with practical expertise in clinical medical technology and the development of innovative medical devices.
  
  
• Fraunhofer Institute for Biomedical Engineering IBMT
  The Fraunhofer IBMT offers extensive expertise in medical technology as well as in the development and evaluation of safety-critical medical systems.
  
  
• Fraunhofer Institute for Experimental Software Engineering IESE
  The Fraunhofer IESE contributes expertise in model-based systems development, safety engineering, and AI-supported assistance systems.