Competences

Project management, including management of contract developers
Development of analog and digital hardware for implantable, portable and stationary medical devices
Software development, including embedded microcontroller software, Android and iOS mobile applications and PC-based software
Development of full product design dossier including risk analysis, suitable for CE-marking and FDA clearance
Development of quality management systems and integration of quality management in design and production
Management and development of intellectual property portfolio
Outsourcing of production (Malaysia and China)
Design of clinical trials and writing of protocols according to Good Clinical Practice.
Analysis of results from clinical trials and writing of scientific articles for publication in peer reviewed journals.
Management of regulatory affairs, such as communication with notified body and management of regulatory submissions