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 ...

LINTHICUM HEIGHTS, MD – Sponsors interested in getting their medical device applications approved by the US Food and Drug Administration (FDA) should have robust design controls in place to ensure ...

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, ...

Remaining competitive in the medical device market requires the ability to improve quality while reducing costs. Sartorius offers various solutions to improve productivity and meet rigorous compliance ...

There is a chronic need for medical devices for the diagnosis and treatment of patients in low- and middle-income countries (LMICs) 1. The current medical device market is not providing affordable ...

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.

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 ...

Key Takeaways Prototyping accelerates the medical device development journey, enabling rapid iterations based on user ...

The manufacturer of pediatric care beds is adding a safety feature after at least one child died in an avoidable accident.

Small-scale wireless soft robotics can be designed as implantable, interventional or wearable devices for various biomedical applications. Their flexibility, dexterity, adaptability and safe ...

ORLANDO – During the HIMSS24 panel discussion "Securing the Modern Connected Hospital," James Angle, product manager of information security at Trinity Health, and hacktivist for hire Kevin Johnson, ...