In January 1990, FDA published Device Recalls: A Study of Quality Problems (55 FR 21108, May 22, 1990). The study reported that 44% of quality problems were attributed to errors or deficiencies that ...

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 ...

Flexible heaters are used in a wide range of medical and diagnostic devices. They play a crucial role in thermal control for applications such as nebulizers, respiratory humidifiers, blood analyzers, ...

Medical devices play an essential role in improving the quality of human life. Consequently, their design poses unique engineering challenges. Designers must address high standards of reliability, ...

When it comes to medical device design—a broad category that includes a range of different machines performing countless critical functions—the stakes are high. Because no matter the application, ...

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 ...

It’s been over 15 years, but the advent of Apple’s iPhone still represents one of the biggest paradigm shifts in the world of consumer technology. It fused style with substance; form with ...