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 ...
MedTech Dive

Human factors isn’t a checkbox: What FDA’s eSTAR requirements mean for MedTech submissions

Most medical device manufacturers start their consultation with me asking one of two questions: “Do we need a human factors ...
Ohsonline.com

Systems Safety: The Critical Role of Human Factors and Ergonomics

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 ...
MD&M East

FDA Finalizes Human Factors Guidance in Combination Medical Devices

Replacing a draft guidance issued in February 2016, FDA recently finalized its guidance on the use of human factors engineering (HFE) in the development of combination medical devices with a drug or ...
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 ...