U.S. and EU regulators require human factors and usability testing to bring a medical device to market. Virginia Lang, PhD, president and chief scientist at HirLan Inc., an engineering consultancy ...
The US Food and Drug Administration (FDA) on Tuesday released new draft guidance to inform medical device manufacturers which device types should have human factors data included in premarket ...
The FDA released updated guidance on May 29, 2026, formalizing expectations for human factors information in medical device ...
Federal regulators and academic researchers are converging on a shared warning: AI-powered medical devices will not deliver on their clinical promise unless developers and oversight bodies treat the ...
In the ever-evolving landscape of healthcare technology, robotic surgery has emerged as a groundbreaking innovation, offering unprecedented precision and control in surgical procedures. Leading ...
A door plug blew off Alaska Airlines Boeing 737 Max 9 mid-flight in January 2024. Now the National Transportation Safety Board says it can happen again. When it comes to safety in the workplace, there ...
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