Software as a medical device

Software as a Medical Device

We have worked on a variety of medical device software development projects and provide a software development process that reflects the full software life cycle of IEC 62304.

We will support you in preparation of the technical documentation including the risk management process according to ISO 14971, usability engineering file according to IEC 62366, quality management according to ISO 13485 and regulatory aspects for both the European and US markets.