Device development

Motivated to fulfil special tasks

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.

We document all the processes in the device master file, implement the risk management accordingly, and we carry out the required tests (EMC and ESD as well as radio tests, when indicated) throughout the developing process in order to finally verify the product. All this is done in compliance with defined norms regarding technical requirements (e.g. IEC 60601) as well as methodical standards (ISO 13485).

Finally: production transfer, product care, and life cycle management are realized smoothly and reliably

What this means: guaranteeing success in all stages of development (starting phase, authorization, production).