Medical Device Human Factors

Ensure your medical devices are examined from every angle

When you need to ensure that your medical device is performing at the highest standards, objective human factors analysis is vital. Ģ��tv assists medical device manufacturers in developing and navigating regulatory roadmaps — from proof of concept, through development, to premarket regulatory submissions, to post-market safety and efficacy management.

Medical device design and user interaction testing.

Medical device design challenges include technological complexity, interactivity with associated devices and services, and compliance with FDA and EU medical device industry regulations. Manufacturers and developers must integrate safety, anthropometrics, and different user environments into their product lifecycles to mitigate use-related hazards and risks.

Ģ��tv's medical device support is a unique offering, combining scientific disciplines of human factors with mechanical and biomedical engineering to provide bespoke product support — from registration, to regulatory compliance, to post-market activities.

At our 6,000 square foot, multiuse Centers for Scientific User Research (CSUR) lab, we conduct simulated use tests, user group evaluations on intended populations, and use-related hazards analysis in risk management for a wide range of medical devices and components. We also offer documentation and labeling, and post-market 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:

• Preparation of robust FDA and EU regulatory submissions

• Design and testing of device labeling and effectiveness of instructions

• Risk assessment support based on post-market surveillance data analytics

• Risk evaluation with human factors failure mode and effects analysis/usability hazards, and fault tree analysis

• Multimodal approaches for collecting behavioral, psychological, and physiological measures to support the design phase

• Conducting robust and relevant preclinical validation testing that considers human interaction factors

• Risk management planning and documentation of HF/UE testing

• Product liability and risk mitigation analysis (design, labeling/IFU)

Our Capabilities Are Unparalleled

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.