Human Factors & Usability for Medical Devices

Get the Human Perspective on Your Medical Devices

Objective human factors analysis is vital to developing medical devices that perform effectively in the hands of real-world patients and healthcare providers. Ģ��tv assists manufacturers with human factors and usability design evaluations for medical devices, in vitro diagnostics, and combination products — from registration, regulatory compliance, use-related risk management, and usability assessments to postmarket activities.

Medical device design and user interaction testing

Design challenges for medical devices, combination products, and in vitro diagnostics, include technological complexity, interactivity with associated devices and services, and compliance with medical device regulations and industry best practices. Many manufacturers and developers integrate usability assessments into their design process to identify and mitigate both foreseeable and unforeseen use-related hazards and risks.

Ģ��tv offers unique medical device evaluations, integrating human factors with mechanical and biomedical engineering to provide bespoke product support — from proof of concept, through development, to premarket regulatory submissions, to postmarket safety and efficacy management.

Ģ��tv has multiple user study labs for conducting simulated-use tests, user group evaluations on intended use populations, and use-related risk analysis (URRA) in risk management for a wide range of medical devices and components. We also offer evaluations of use-related documentation and labeling and postmarket surveillance support.

Download our medical device human factors brochure to learn more.

Services

For 50+ years, we've thrived on solving unstructured problems that require bespoke solutions. Some of our services include:

What Can We Help You Solve?

With expertise in over 90 disciplines and hundreds of capabilities, tools, and methodologies — we get to the root of even the most complex challenges and give you the objective answers you need.