Human factors (or usability) studies are intended to demonstrate the performance of a device without going to the expense of clinical trials, but within an environment that simulates its environment of use and by the variety of people who might be users. A well designed study will identify any safety or application problems. It can include user interaction with devices, systems, software, apps and instructions for use.
Medical engineering technologies can offer these studies for all types and classes of device. We have conducted studies in North and South America, Europe and Asia. The service always follows MHRA and FDA Guidelines and the investigation may be formative or summative.
Software validation is a difficult issue to resolve, the more simulated use a product has the better. This particularly applies to intensive care monitors, ventilators, IVDs and administration equipment. Usability studies for software and hardware can be combined with risk analysis and iterative design in a usability engineering process.
When it comes to performing human factors testing, compliance is key to ensuring a cost-effective, timely solution. If you want to keep your product development on track, then MET can be your partner of choice to perform human factors testing with.