Human factors engineering
In medical engineering, "human factors engineering" increasingly replaces the common usability concept, not at least because the FDA claims that usability is often understood as design.
Human factors engineering across all industries focuses on the conditions that facilitate human actions in complex technical environments, in particular human-machine systems, and help to make them more efficient, while maximizing safety and increasing satisfaction. And therefore IEC 62366 also defines usability as the characteristics of the user device interface related to the effectiveness, efficiency, conduciveness, and user satisfaction.
Integrating human factors engineering into the product specification serves the specification of important application requirements linked to the use of the medical device, such as general usability and safety aspects.
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Our services in detail
- Developing the process of ergonomic design (human factors engineering) and design validation for the development of medical devices.
- Analyzing, specifying, designing, and validating the characteristics of a medical device in terms of its application to ensure usability.