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 ...
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 ...
Business Wire

Rimkus Acquires Human Factors Consulting Services, Incorporated, Enhancing Expertise in Human Factors and Medical Device Consulting

HOUSTON--(BUSINESS WIRE)--Rimkus Consulting Group, Inc. (“Rimkus”), a premier global provider of engineering, technical consulting, and life sciences services, is pleased to announce the acquisition ...
Business Wire

Human Factors and Ergonomics Society's Human Factors Journal Receives Prestigious Recognition

WASHINGTON--(BUSINESS WIRE)--The Human Factors and Ergonomics Society (HFES), the world’s largest scientific association for human factors/ergonomics professionals, announced that the society’s ...
JD Supra

FDA Clarifies The Human Factors Or Usability Information To Include In A Device Marketing Submission

Brandy Guarda, Regulatory Analyst in Washington, D.C., contributed to the drafting of this post. If you are a device manufacturer, what human factors and usability information should you include in ...
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 ...
iaea.org

Technical Meeting on Safety Considerations in the Use of Artificial Intelligence in Nuclear Power Plants with a Focus on Human Factors Engineering and Instrumentation and ...

As artificial intelligence (AI) technology rapidly advances and becomes widely integrated into industries and our daily lives, the nuclear industry is also exploring the use of AI applications. To ...