Development: -Broad experience in development of medical devices, especially single use devices and implants. (example: www.easyvial.com) -Experience with patent research and application for various medical devices. -Cooperation with a broad range of medical device manufacturers in Germany. Regulatory Affairs: -Expert for clinical affairs with specialty in clinical evaluation of medical devices. -Expert for technical documentation with specialty in Summary technical documentation (STED). -Expert for demarcation of medical devices and medicinal products. -Specialist for quality managment and risk management for medical device manufacturers. Goals: -Building up the international branch of our regulatory compliance services, especially US and latin american buisiness.