Explore FDA's QMSR and cybersecurity mandates for medical devices, including SPDF, SBOMs, and legacy medical device ...
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 ...
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 ...
Teasing out key trends and themes with Mark O’Shea, senior business development manager for Nordson EFD. Booth demonstrations highlighted automation, connectivity and process ...
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, ...
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, ...
Designers and engineers have often looked to the environment and how Mother Nature has accomplished phenomenal design solutions for inspiration over the ages. Perhaps all that is new about this ...
The integration of artificial intelligence (AI) into the design of medical devices heralds a new era in healthcare—one where innovation meets precision to significantly enhance patient outcomes. This ...
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