RED Group International - Human Factors Center of Excellence

Human Factors Consultants

Human Factors Testing

Safe and Effective

Medical Device Human Factors

RED Group International - experts in Medical Device Human Factors, ensuring your products are Safe and Effective, when used by their intended users, in their intended use environment. Human Factors Research, Evaluation, and Design is our passion.

Whether you are looking for FDA and/or CE Mark approval, we are here to help. All work performed by RED Group is in accordance with IEC/ISO 62366-1:2015, ANSI/AAMI HE75:2009 (R) 2013, and Applying Human Factors and Usability Engineering to Medical Devices, Guidance for Industry and Food and Drug Administration (FDA), Feb. 3, 2016.

We are often asked, “What is Human Factors?” Human Factors is a scientific discipline that studies how the human interacts with devices, products, and/or systems. Human Factors Engineering is based in research, scientific/experimental method, statistics, human physiology, and cognitive information processing.

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It is the combination of engineering, human physiology, behavioral performance and cognitive science with the single goal of ensuring your products are Safe and Effective, when used by their intended users, in their intended use environment. Human Factors Engineering approaches design with the User as the focal point (User Centered Design). However, we take that one step farther including all product stakeholders to ensure the product is also profitable. User Centered Participatory Design helps ensure you deliver the “right” device at the “right” time.

Our approach is simple: Based upon proven process, best practice, and applicable guidance/regulations, we are committed to being an integral part of your team, and providing a customized, flexible approach to meet your individual needs and requirements. We provide the highest level of Customer Satisfaction and Respect. RED Group International strives for Excellence in all we do to ensure we meet, and/or exceed our Customer’s Expectations. RED Group International is ISO 9001:2015 compliant.

Call us. We will answer any question you have. We are happy to assist you!

Contact Info

1011 Camino del Rio South, Ste 405
San Diego, CA 92108

Telephone: (619) 955-7795

RED Group International specializes in Human Factors (usability). All work performed by RED Group International is in accordance with IEC/ISO 62366-1:2015, ANSI/AAMI HE75:2009 (R) 2013, and Applying Human Factors and Usability Engineering to Medical Devices, Guidance for Industry and Food and Drug Administration, Feb. 3, 2016.