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 ...

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 ...

Industry groups and companies in the medical device sector are urging the US Food and Drug Administration (FDA) to utilize its existing quality management systems (QMS) requirements to oversee the ...

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, ...