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Usability testing for medical devices

Our thorough usability testing service for medical devices adheres to the IEC 62366 ISO directive, guaranteeing the safety and efficiency of your product for its users.

We can help you in the journey of launching innovative life-changing medical devices and/or assuring ongoing compliance with regulatory frameworks.

Our Researchers have an extensive knowledge of patient safety and medical device usability and will help you apply the HF/UE to your medical device.

Our team can take care of the entire process, end-to-end. We can design and execute an ad-hoc research plan, involving the the most appropriate techniques for your product (survey, In-depth Interviews, Usability test of the medical device, etc.) and the stage it is in. We are commited to creating safe and valuable experiences for your patients and healthcare professionals.

Our medical device usability validation process

01

Identifying users and user scenarios

We determine who are the intended users of the medical device and the tasks they are expected to perform with the device in real life situations.

02

Defining test protocol and risk analysis

We identify known or foreseeable hazards associated with the medical device's use and establish the evaluation plan, including methodology (formative or summative research), objectives, and success criteria.

03

Conducting a usability test

We observe participants as they use the medical device to perform the specified tasks, and record their feedback.
This includes performing a root cause analysis of the problems emerged during the session.

04

Analyzing and documenting

We analyze the data collected during the usability test, providing quantitative insights and concentrating on all the underlying factors of each specific issue.

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State of the art facilities

Our Madrid-based lab is fully equipped to conduct usability testing on a wide range of medical tools:

Devices, including injection devices, infusion pumps, and transfer devices.
Instructions for Use (IFU) accompanying these devices.
Packaging and labeling of medical products.
Medical software for both mobile and desktop platforms

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More ways of testing and optimizing your product

Testing and optimization are key to creating exceptional user experiences.
We provide thorough testing to find where changes can make a difference and help your products be successful.
Our experienced UX researchers offer clear insights, both qualitative and quantitative, and recommendations to help you continually improve your experiences.