How to bring your medical technical solution to the European market
The medical industry is a large work area with a huge potential for creative problem-solving and high-tech solutions. Universities and other educational institutes, however, hardly provide any classes on bringing to market your medical devices. Unitron has successfully developed, manufactured and supported certification of electronic medical devices for the European and American markets. Using practical examples, we will outline in this talk the key aspects you need to understand for becoming a successful medical device marketing business or supplier. Topics covered include medical device regulations, quality management systems, medical device safety and performance, conformity assessment, risk management, medical software and post-market surveillance.