Webinar on Major Considerations for Expanding your Quality System requirements (QSR) from Medical Devices to Combination Devices24/10/2014
Differences in regulatory requirements between Medical Devices and Pharmaceutical products poses unique challenges to companies that want to manufacture devices that contain drugs and biological products (aka Combination Devices). Large and small medical device companies who want to embark into this new journey by adding a coating of a slow eluting drug product to their medical devices face challenges that range from facility design, changes in testing requirements to evaluation of major considerations in navigating their regulatory path to fulfilling the quality system requirements (QSR) in the ever changing, fast growing, complex arena of medical devices and pharmaceutical GMP considerations under one QSR umbrella.
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