Usability testing focuses on measuring a human-made product's capacity to meet its intended purpose.

Medical device design needs to incorporate human factors engineering to ensure that the product is safe and easy to use, and that it accommodates a broad range of user capabilities and environments. Any potential hazards caused by the usage of the device should be identified and investigated throughout the product life cycle using risk analysis and usability testing.

Incorporating usability testing, which complies with the international standards HE75, IEC 62366:2010 and the FDA guidelines helps a company address patient needs, ensures positive patient outcomes, and encourages therapeutic compliance.

Our team of experienced professionals can assist you with the design of your device’s usability studies and tests to validate the product’s usability through formative and summative assessment.

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