we offer

Use Related Risk Analysis (URRA)

URRA is a corner stone of usability engineering. Documenting the possible risks related to the use of a medical device is an extremely important task and one highly required by the medical authorities like e.g. the FDA.

Technolution can help clients identify all relevant steps of user interaction and the potential use errors that may occur when using a medical device. What are the resulting hazards, and what kind of mitigations are needed to prevent these from happening? The value of capturing the entire story about use related risks cannot be overstated.

A unique trait of our usability engineering team is the strong connection with design control specialists. The findings and data gained during the URRA must be traced back to other activities to ensure that the device specifications align with the user needs and the intended use of the device