MD&M East

Human Factors Testing Is the Key to Approval & Profitability in the Medical Device Industry

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 ...
RAPS

Human Factors Review: FDA Outlines Highest Priority Devices

The US Food and Drug Administration (FDA) on Tuesday released new draft guidance to inform medical device manufacturers which device types should have human factors data included in premarket ...
Medical Device and Diagnostic Industry (MD+DI)

Why FDA's Latest Guidance Makes Human Factors a Make-or-Break Issue for Device Approval

The FDA released updated guidance on May 29, 2026, formalizing expectations for human factors information in medical device ...
Hosted on MSN

Researchers urge human factors focus for safer AI medical devices

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 ...
Forbes

Beyond The Code: Human Factors In Robotic Surgery Risk Management

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 ...
RAPS

FDA provides additional examples, clarity in human factors guidance

The US Food and Drug Administration (FDA) has finalized a revised draft guidance from 2022 on what human factors (HF) information sponsors should include in premarket submissions for medical devices.