Usability Engineering File
The usability engineering process covers the entire product development and significantly supports your development engineers. The results are recorded in the usability engineering file, which you as the manufacturer or distributor need to provide to document the application of your medical device.
The analysis phase analyzes and documents the requirements of the different user groups and usage environments. The results are also adopted into the product requirements and are therefore available to the developer. Continuous tests and inspections of usability at different development stages of the product examine whether the development process is purposeful. This avoids expensive loops in the development process, which especially important for software developments. The validation stage examines and verifies whether the requirements in terms of usability are met.
For existing devices that are already available on the market, the process is different: If feasible, instead of a validation study, incidents and failures of the device and comparable competitive devices may be subjected to analysis and the evaluation used as proof of compliance with usability requirements. The usability engineering file, however, follows the same outline and structure as in a new development.
Our usability team has the required experience to support your in-development process efficiently; furthermore, we work with the appropriate partners for planning and conducting the study.
For legacy systems put into service before IEC 62366 took effect, we develop the usability engineering file at a fixed price, provided that all required documents are available.
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Our services in detail
- Developing the usability engineering file,
- Aligning the content with the risk management file,
- Organizing and involving usability experts for conducting customer surveys and validation studies,
- Training and consulting how to implement the requirements of IEC 62366 in practice.