How we minimize use-related risks in safety-relevant medical solutions with medical usability and human factors engineering.
With our Human Factors and Usability Engineering competencies, we support companies in safety-relevant industries to minimize usage-related risks in their products, workflows or processes in order to avoid undesired events such as accidents or product recalls:
Identify and mitigate usage-related risks
Using human factors tools and methods (e.g. use error analysis), we create the basis for the analysis of user interactions and identify potential use-related sources of risk in your products, workflows or processes. The goal is to correctly classify the severity of the use-related risk and to design the respective solution or risk mitigation.
Demonstrate effectiveness by means of formative and summative evaluations
With formative and summative usability evaluations, we check and assess the usability as well as the effectiveness of the defined risk mitigation in the different phases of the product development process. Products, processes as well as trainings and instructions for use can be tested for their safety of use, in order to finally provide evidence for a safe product or process application.
Create usability documentation for medical device approval
We take over or advise you in the planning of the usability engineering process during the development of safety-relevant medical devices. For this purpose, we document all approval-relevant evidence in the usability engineering file according to IEC 62366-1 or in the HFE\7UE reports according to FDA Guidance.
The aim of this process is to achieve the best possible device quality in order to meet the expectations of the regulatory authorities regarding the usability of the device.
User-device model / PCA-analysis
Use risk history analysis
Identification of use related hazards
User interface design requirements
Hazard severity analysis
Labeling design requirements