Support during development and development of medical software according IEC 62304/IEC 82304

PROSYSTEM AG supports you with the implementation of a software-lifecycle process according to IEC 62304 in order to meet regulatory and normative documentation requirements. Our specialists will support you during the software development and the preparation of the technical documentation including the risk management process and the usability engineering file for medical software.

Our testing engineers validate your medical device- or process software either on site or in our office according to the state of the art. Naturally PROSYSTEM AG also offers complete software development according to your specifications.