Planning and designing for usability during the product development process is a key element in ensuring regulatory compliance.
Usability and human factors engineering (HFE) are core components embedded in every biomedical device development project at Invetech. Addressing usability starts at the product definition stage, helping produce a design early on that is inherently innovative and that prevents user errors.
Building on the foundational insights uncovered through experience design research, our multidisciplinary engineering and design teams initiate a process beginning with early prototypes to ensure development of a safe and usable medical device that minimizes the risks linked to use errors. In overview, the process involves the following:
Identifying anticipated use-related hazards
Developing and applying measures to eliminate or reduce those use-related hazards
Demonstrating that the device user interface design supports safe and effective use by conducting usability testing with representative users and in the environment of use
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