Managing risk is a fundamental aspect of medical device development, and at confinis, we provide comprehensive risk management services aligned with ISO 14971. We assist clients in identifying, assessing, and mitigating risks throughout the product lifecycle. Our services also extend to Human Factors Engineering (HFE) and Usability Engineering, which are essential for ensuring that devices are safe and effective for end-users.

Our team conducts detailed risk analyses, including Failure Mode and Effects Analysis (FMEA), to identify potential hazards and their mitigations. We also perform usability studies to understand how users interact with devices, identifying potential use errors and designing solutions to prevent them. This holistic approach to risk management not only ensures regulatory compliance but also enhances the safety and usability of the product.

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.