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Smart Vigilance

Smart Vigilance – Research project on post market surveillance of medical devices relies on state-of-the-art methods of artificial intelligence

The go-ahead was given in August 2019: together with our project partners DHC Business Solutions and the German Research Center for Artificial Intelligence, we are making every effort to make post market surveillance for medical technology even more efficient and to improve patient safety.

The aim of the project is to develop a new service platform that will simplify and make more reliable the market observation (post market surveillance) and risk assessment of medical devices. State-of-the-art technologies and methods of artificial intelligence (AI) will be used. The research project SmartVigilance is funded by the Federal Ministry of Science and Research.

Manufacturers of medical devices are subject to strict regulations regarding the safety of their products. Regulations concern both product approval and the phase after market launch. Companies are obliged to monitor their products on the market and in use as part of post market surveillance (PMS) and to take appropriate measures to eliminate possible defects or reduce risks for patients.