One of our key competencies at confinis is to construct medical devices so that the risk of application error is reduced as much as possible. This is achieved through the implementation of usability engineering procedures in accordance with IEC 61366-1 and FDA guidelines warranted from the beginning of the product development. The usability engineering procedure is therefore closely linked to the risk management procedure.

We will gladly assist in the creation or improvement of your usability engineering procedure and facilitate the transfer of individual process steps, such as task analysis, risk analysis for application error, specification of the usability requirements, creation of validation plans, development-process usability tests, as well as verification and validation of the usability.

In addition, we are glad to offer the creation of a standardized usability engineering file, including the closing report according to FDA requirements.

Why is it important?

Human factors/usability engineering focuses on the interactions between users and devices and serves to minimize application error related risks.