FDA and international human factors engineering guidelines agree that manufacturers can disregard Abnormal Use when it comes to medical product usability testing. However, the specific meaning of ...

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 ...

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 ...

Association for the Advancement of Medical Instrumentation Brings Human Factors Guidance up to Date Arlington, Virginia--(Newsfile Corp. - November 18, 2025) - How medical professionals interact with ...

Before you get started on any medical device design engineering project, it is essential to understand user needs, explains Philip Remedios, CEO and director of design & development for BlackHägen ...

These definitions as written out by AAMI (The Association for the Advancement of Medical Instrumentation) offer clarity, helping designers recognize and address these risks effectively in product ...

HOUSTON--(BUSINESS WIRE)--Rimkus Consulting Group, Inc. (“Rimkus”), a worldwide provider of forensic engineering and technical consulting services, today announced the acquisition of Core Human ...

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 ...

Human factors (also referred to as human factors psychology and human factors engineering) is an applied field of study that examines human abilities, limitations, behaviors, and processes in order to ...

Medical device design and development has evolved over the years, notably influenced by market demands and regulatory requirements. Traditional design practices, beginning with a reliance on generic ...

HEART and HEP methodologies present opportunities in enhancing human error assessment and risk management, particularly within R&D environments focused on device design. By integrating these ...