The FDA import alert broadens the scope of a 2025 import action covering dozens of endoscopes and comes two weeks after a new ...
Olympus (TSE:7733) received a Warning Letter from the U.S. FDA following inspections of several international facilities. The ...
The Quality Management System Regulation replaced QSIT inspections and made ISO 13485:2016 the reference standard for US medical device manufacturing. Soft contact lenses are not exempt. The U.S. Food ...
The US Food and Drug Administration’s (FDA) final guidance on software assurance in computer and data processing systems for medical device production includes more examples and a new section ...
The US Food and Drug Administration (FDA) sent warning letters to two major healthcare product manufacturers—Baxter ...
Dublin, June 28, 2024 (GLOBE NEWSWIRE) -- The "The US FDA QMSR Transition - 21 CFR 820 and ISO 13485" training has been added to ResearchAndMarkets.com's offering. The US FDA, after years of ...
ComplianceQuest's AI-powered Connected Quality, Risk and Compliance (QRC) platform to be delivered across FDA under ...
The FDA's 21 CFR Part 820 and ISO 13485 are crucial in regulating medical device quality systems. Harmonizing these standards by 2026 will streamline compliance, improve patient access to devices, and ...
Fulfilling the required changes to FDA’s quality management system regulation (QMSR) ahead of February 2026’s compliance deadline is much ado about nothing for most companies, according to Kim ...
The United States Food and Drug Administration (FDA) has released updated cybersecurity guidance titled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket ...
The U.S. Food and Drug Administration (FDA) recently finalized its guidance document, Computer Software Assurance for Production and Quality System Software, for software used in device production and ...
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