The development of a complete device or system is a complex task. The whole range of technical team competencies are required in the process, and the “agile V” reveals its full potential.
Naturally, regulatory requirements regarding technology and documentation serve as a basis for any task in device development. It is the final CE-authorization of the product that determines the success of a project. Comprehensive knowledge of “Medical Device Regulation“ (MDR) as well as ”In Vitro Diagnostic Regulation“ (IVDR) is prerequisite. The compliance with “Basic Safety“ and “Essential Performance“ regulations is ensured.