Medical device design and development is a process that helps to ensure devices that go to market are safe, effective, marketable, and profitable. The process is a blueprint of the phases needed to ...

In the medical device industry, usability plays a critical role in ensuring the safety and effectiveness of highly complex medical products. The IEC 62366-1:2015 standard, which focuses on the ...

Medical devices—whether compact, in-home tools like blood pressure monitors or large, sophisticated diagnostic systems used in hospitals and laboratories—are increasingly designed for global markets.

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 ...

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 ...