An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken. Medical Device Reporting (MDR) is the mechanism for FDA to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly. Recall means the correction or removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death. It is an action taken to address a problem with a medical device that violates FDA law.
25 Jul 2013 @ 09:00 am
26 Jul 2013 @ 06:00 pm
Duration: 1 days, 9 hours
Courtyard Boston Logan Airport
201-349 William F McClellan Highway
Harbor View / Orient Heights
Organised by GlobalCompliancePanel (deactivated)