RED Group International Logo - medical devices

RED Group International

medical devices
China's Best One-Stop Medical Equipment Provider
About

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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Keywords
summative validation military medical device civilian medical device ce mark human factors for life design us fda human factors design ui design iec 62366 formative evaluation combination product human factors development lean six sigma medical device human factors iso 62366 human factors center of excellence he75 human factors
Company Information
  • Employees 0
  • Founded 2017
Location

2840 5th Ave, San Diego, California, United States, 92103

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