Usability Assessment

The error-free and hazard-free use of a medical device are the results of a usability-oriented product development. The successful implementation of usability must be documented for each medical device in the form of an assessment report as part of the conformity assessment procedure according to the EU Medical Device Regulation (MDR) in accordance with DIN EN 62366-1.

The assessment of usability is an essential part of the technical documentation of a medical device.

BEO BERLIN undertakes the assessment in a practical environment and prepares the report for you in accordance with DIN EN 62366-1.