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FDA QMSR Through The Lens Of Risk Management
Edwin Bills, Christie Johnson, and Jayet Moon describe how the new QMSR was shaped by ISO13485:2016 while still retaining its core. They explore how risk management is a key focus, with an emphasis on integrating risk-forward thinking throughout the QMS.
Intersection of ISO 13485 and ISO 14971 under FDA QMSR
The most popular guest column of 2023 for Med Device Online! Edwin Bills and Christie Johnson describe the intersections of ISO 13485:2016 medical devices quality systems standard and ISO 14971:2019 medical device risk management standard, which the FDA believes is key to the new QMSR.