Human Factors ensures your products are Safe and Effective, when used by their intended users, in their intended use environment. RED Group International specializes in Research, Evaluation, and Design (RED Group International). We are experts in Medical Device Human Factors and both FDA and CE Mark regulations/guidances. 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.
Human Factors Engineering is based on research, scientific/experimental method, statistics, human physiology, and cognitive information processing. It is the combination of engineering, human physiology, behavioral performance and cognitive science. Human Factors is a scientific discipline that studies how the human interacts with devices, product, and/or systems. Human Factors Engineering approaches design with the User as the focal point. Human Factors Engineering assures devices, products and systems are Safe, Effective, and Usable by their intended Users, in the intended use environment.
Our approach is simple: Based upon proven process, best practice, and applicable guidances/regulations, we are committed to being an integral part of your team and providing a customized 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, or exceed all Customer Expectations.
Call us. We will answer any question you have. We are happy to assist you!
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