Safe Handling of Hazardous Drugs: ASCO Standa...
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The packaging of medical devices, especially sterilized products, is often overlooked and does not make news headlines until it’s done wrong. How can packaging and labeling prevent 510(k) delays? In this episode of the Global Medical Device Podcast, Etienne Nichols ...
FDA has proposed a new rule to align its Quality System Regulation (QSR) with ISO 13485:2016, the international standard for medical device quality management systems. How will, what's being referred to as Quality Management System Regulation (QMSR), affect the medical device ...