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Human Factors in Medical Device Design Sponsored by:
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The term human factors is very important to those who develop and market medical devices. Creating simpler, safer, more user-friendly products is a key objective for medical device manufacturers wishing to be competitive in today's medical device markets. Medical device manufacturers are required by FDA and other international regulatory bodies to demonstrate how human factors considerations were met during their product's development. A panel of experts will provide tips for integration of human factors into the product development process, clarify regulatory obligations and review the rationale behind these requirements, discuss how to strengthen regulatory submissions by highlighting human factors activities and findings and provide guidance on the difficult issue of how to determine the right level of investment in human factors given a device's inherent risk.
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