Making People’s Life Easier

We are a Usability Engineering and Human Factors service provider for medical devices and digital healthcare products. We collaborate with MedTech and Digital Health start-ups at all stages of their development process.

Why you need Usability Engineering

Two reasons, quite simply.

Firstly, by applying usability engineering early and often in the development process, you quickly and economically uncover any issues and use risks about your product. Then, the design can be refined to improve safety, mitigate risk, minimise development costs, comply with regulatory requirements and maximise market adoption potential.

Secondly, to legally market your device in US, AU, EU or APAC regions, your regulatory submission requires evidence of usability engineering.

Our team specialises in compliance to FDA guidances and IEC62366; internationally recognised human factors standards in the medical device industry. If you’re looking for additional project resources, expert advice on your human factors regulatory submission, or someone to manage and lead your usability engineering efforts, Sento’s team of expert consultants are here to help.

There is no medical device that doesn’t benefit from good usability.

User Research

We plan and conduct targeted research with your major stakeholders to validate your market assumptions and identify end-user and patient needs.

Formative & Summative Studies

Getting your product into the hands of your users to make it safer and easier to use.

Usability Engineering

Generation of all usability and human factors regulatory outputs to comply with standards and guidances across the US, Australia, Europe and APAC regions.