Dublin, Sept. 23, 2025 (GLOBE NEWSWIRE) -- The "Bottlenecks to Flow: Optimizing Design Controls and Validation in Medical Device QMS (Oct 23rd - Oct 24th, 2025)" training has been added to ...

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 ...

Dublin, Sept. 22, 2025 (GLOBE NEWSWIRE) -- The "US FDA Medical Device Quality System (QSR) Compliance: Design Controls, Verification & Validation (Oct 27th - Oct 28th, 2025)" training has been added ...

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 ...

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 ...

Medical device product development is a highly integrated and regulated process. Implementation of a requirements tracking solution requires attention to a variety of nuanced topics. When presented ...

Hospitals and healthcare facilities are grappling with high turnover among nurses and medical technicians. This is a challenge that’s reshaping medical device design. As staffing shortages make ...

Design controls sit at the center of the Quality Management System Regulation (QMSR). Design controls sit at the center of the Quality Management System Regulation (QMSR). They govern how medical ...

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 ...

Secure by design didn’t just pop up in the medical device industry with the update to the Food & Drug Administration (FDA) guidance on cybersecurity recommendations. However, its inclusion in this ...

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, ...