Reflections A newly regulated medical device industry found itself in need of lots of training. FDA and industry worked closely together to make it a success. Andrew Lowery Andrew Lowery spent 20 ...
Following the most recent revision to the EU GMP Annex1 in 2020, Eric Clement Arakel (Global Product Manager) and Myriam Gueye (Segment Marketing Manager, Applied Industries) at Sartorius will explain ...
Outsourced medical device production offers a manufacturer the opportunity to enhance its production bandwidth, its technological capabilities, and ultimately, its profit margins. It is no surprise ...
On February 2, 2024, the US Food and Drug Administration (FDA) published a much-awaited final rule: the Quality Management System Regulation (QMSR). 1 By issuing this rule, FDA amended the medical ...
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