Articles by Natalie Abts
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Final FDA Human Factors Guidance: 10 Updates That Affect Your Validation
4/16/2016
FDA’s final human factors guidance expands upon the importance of incorporating a robust human factors approach throughout the design and development process, resulting in devices that are safe and usable for the intended user population in the intended use environment. Anyone planning to seek device approval through the 510(k) or PMA submission processes should note these 10 critical updates concerning device validation.
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How Medtech Companies Can Reduce Costs And Increase Revenue Through Human Factors
2/3/2015
Healthcare is a more dangerous industry than most people realize. People are often surprised when they hear that medical error is the third leading cause of death in the United States, especially considering our expectation that healthcare is here for our benefit. Despite numerous regulations and initiatives focusing on this problem, the magnitude of medical errors persists.