![]() ![]() ![]() Still, the organization remains optimistic about publishing an updated regulation. Facing an April 2020 publishing deadline, the project was once again delayed due to the agency’s all-hands priority given to coronavirus-related activities. Since 2018, the FDA has endeavored to retool its QSR to harmonize with the ISO 13485:2016 standard. What is the status of the FDA’s QSR/ISO 13485:2016 Harmonization Effort? This post addresses some of the most frequently asked questions about ISO 13485:2016. Food and Drug Administration (FDA) has announced intentions to harmonize the Quality System Regulation (QSR) for medical devices to align more with the 13485 standard. The guidelines provide medical device manufacturers with a framework for establishing a quality management system (QMS) relevant to their industry and products. It’s been five years since the International Organization for Standardization (ISO) published the ISO 13485:2016 standard.
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