Human Factors testing of baby-care monitor

Human Factors Testing

Formative and summative human factors testing for the Medtech and Connected Health industries – ISO 13485 standards compliant.

Human Factors are an increasingly important regulatory component in the design of medical devices and Connected Health products. As greater functionality and complexity increases the risk of user error and placing a greater reliance on user training.

Medical devices and drug therapies have become more diverse with a greater reliance on digital technology. With a move towards remote monitoring and home-based healthcare the end users of these products have become less skilled and in some cases, the end user is the carer or patient themselves. On a basic level, it is critical that these devices can be used safely without error. Looking to the future, it is important that patients engage with these technologies over the long term, to ensure that they adhere to their therapy and experience positive outcomes. has extensive experience in human factors research and design of Class I and Class II medical devices. We provide an end-to-end medical human factors service including formative research with patients, carers, and healthcare professionals, and summative testing of devices with intended user profiles in accordance with ISO 13485. We have conducted research in hospitals and clinics across the USA and Europe. Our highly experienced usability and user testing team work closely with our medical device designers to ensure research findings lead to product solutions.

Testing a blood glucose monitoring device.

Do you have a project in mind?

Our Human Factors team is based in our studio in Dublin, Ireland and work with clients all over the world. Our multi-disciplinary team includes business analysis, cognitive psychology, usability, human factors, medical device design, interaction design and user interface design and development skills. We have two decades of experience in delivering medical software, healthcare device interfaces, patient training and instructions, patient apps, and process improvement.

Get in touch today to see how we can help with your upcoming human factors requirements.

Contact our Human Factors Team

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