Project "MedSafe"

MedSafe is a research project aimed at developing a smart tool that helps SMEs and research institutions to efficiently comply with regulatory requirements for medical devices and generate safety documentation in a semi-automated manner.

Navigating Regulatory Complexity

The development of medical devices is subject to strict regulatory requirements. Risk management, in particular, requires specialized expertise and extensive documentation, and ties up significant human and financial resources. Launching new products onto the market is particularly challenging for SMEs due to limited budgets, scarce personnel, and the long time it takes to obtain approval.

The “MedSafe” project aims to create the conditions that will enable SMEs and research institutions to bring their technological developments to market safely, quickly, and efficiently. 

Model-based assistance instead of manual documentation

The goal is to develop an intelligent tool that makes regulatory requirements easy to understand, systematically organizes them, and provides targeted support for their implementation. To this end, a model-based, AI-powered assistant is being developed that guides users through relevant questions and provides structured support for the creation of key safety artifacts. Companies benefit from clear processes, improved traceability, and time savings in their day-to-day development work.

MedSafe is applied and further developed based on typical challenges encountered in the development of modern medical devices.

Complex medical devices with multiple subsystems

MedSafe helps companies systematically identify risks and interdependencies between hardware and software. This enables safety arguments to be consistently derived and transparently documented.

AI-based or software-intensive medical devices

The assistance approach helps to identify regulatory requirements in a targeted manner and apply them to the respective system description. Safety-related artifacts are prepared in a structured manner and generated with support throughout the development process.

MedSafe is a joint research project involving several Fraunhofer Institutes. The aim of the collaboration is to pool expertise and systematically translate scientific findings into practical applications.
 

Participating institutions:

• Fraunhofer Institute for Experimental Software Engineering IESE
  Fraunhofer IESE contributes expertise in model-based systems development, safety engineering, and AI-supported assistance systems.
  
  
• 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 Medical Technology IMTE
  The Fraunhofer IMTE complements the project with practical expertise in clinical medical technology and the development of innovative medical devices.