The new regulation concerning Medical Devices (2017/745) and Diagnostics (2017/746) could have a dramatic impact on SMEs system. Right now, only a small amount of manufacturers are in compliance to the certification processes of the new Regulation. The risk in here is a shortage of Medical and Diagnostics Devices, that can have an effect on European Sanitary Systems, and on the health needs of the patients. How should we handle this challenge? This is the real question about our future. What about MDR and Telemedicine?Continue reading “Impact of MDR on European SMEs system”
Peter Julius and Britt Sørensen have been working within the field of technology testing for many years. Together they have the company Public Intelligence in Denmark and Japan. Public Intelligence has done more than 100 tests for private companies and has tested everything for the ux to the business model and the overall market entry. Come by and listen to why you should consider Denmark as the natural testbed for your internationalisation.Continue reading “Why Denmark is a good testbed for Healthcare technology”
AI is bound to increase the efficiency and effectiveness at which software as medical devices will operate. If that sounds convincing, how to integrate AI in your SaMD from a regulatory and quality point of view?Continue reading “Integrate AI in your SaMD”
Highlights, steps and challenges when implementing IEC62304 and IEC 82304 in the general quality management system for medical device software.Continue reading “Integration of IEC62304 in the Quality Management System under ISO13485”
An introduction in Medical Device Development in Europe, starting with the explanation of roles & regulations and do’s and dont’s in order to get your device on the market.
Followed by an overview of the current situation in the field regarding certification of medical devices and the queues at Notified Bodies.
Closing with some tips to be prepared!