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FDA & Healthcare associate Michele Buenafe will present on the panel "Medical Devices: Latest Enforcement Developments" at the 2013 FDLI Annual Conference.
Medical device stakeholders should be aware of the array of enforcement tools CDRH uses to hold companies accountable, including injunctions, recalls and warning letters. To avoid liability, medical device manufacturers must understand how to comply with the requirements of clinical trials, current good manufacturing practices (cGMPs), and quality system regulations (QSRs). This session will provide practical advice on how companies can avoid and respond to enforcement actions.
Tuesday, April 23, 2013
The Ronald Reagan Building and International Trade Center
1300 Pennsylvania Ave NW