What are the differences between a usability test and a clinical investigation?

Usability testing and clinical investigation are two different approaches to evaluating products, especially in the context of medical devices.

Usability testing focuses on how well a product can be used by users. This includes user-friendliness, efficiency and satisfaction. For medical appliances, this includes aspects such as operation, understandability of instructions and effectiveness of the user interface.

Usability testing typically involves representative users or potential users of the product and follows the requirements of IEC 62366 for the application of usability to medical devices. They are conducted during the development process to improve the product design and tend to be smaller in scope and shorter in duration. The focus is on user interactions, error rates and subjective evaluations.

In contrast, a clinical investigation is an in-depth examination of the safety and effectiveness of medical interventions such as drugs, in-vitro diagnostics or medical devices. The focus here is on the effects on patient health. Participants are carefully monitored to collect data on effectiveness and possible side effects.

Clinical investigations must be consulted by an ethics committee and require a qualified clinical investigation manager.

Usability testing and clinical investigations are essential for the development of safe and effective medical devices, but address different aspects and requirements in the product life cycle.

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