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This blog is part of a three-part series on proven strategies to help avoid QMS implementation failures.  The first blog article describes the best practices approach to building a QMS [...]

The Advanced Medical Technology Association (AdvaMed) wants the Food and Drug Administration (FDA) to understand that medical device manufacturers want clarity on FDA’s heightened focus on [...]

FDA’s Center for Devices and Radiological Health (CDRH) provided a glowing self-assessment in a recent report. The CDRH met its 2016 strategic objectives for several initiatives pertaining [...]