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ISO 13485
2016
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26262
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Navigating ISO 13485, QMSR Alignment, and Manufacturer Accountability | Xcelrate UDI Webinar | Xcelrate UDI
A huge thank you to everyone who joined our foundational webinar, "Navigating ISO 13485 and QMSR Alignment," led by Xcelrate UDI President Joan Melendez! The key message is clear: The FDA's QMSR (effective Feb 2026) is not just a manufacturer problem. It shifts the burden of enforcement to hospitals. If a device’s IFU is incomplete, non ...
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1 month ago
ISO 13485 Explained
ISO 13485: the essential guide
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