This article explores the current state of design controls for software as a medical devices (SaMDs), focusing on the FDA’s ...

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. 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 ...

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 ...

FDA's quality system regulation (QSR) is often perceived by medical product developers as unnecessary overhead. Software developers, in particular, often see it as a nuisance that delays the ...