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Outsourcing and the Device Manufacturer’s QMS Accountability

August 6th, 2015 by

Global Medical Technology ComplianceIn 2003, the [...] Read More

Deciphering the FDA Medical Device QSR

May 1st, 2015 by

Medical Device ManufacturingAs a medical device manufacturer, how do [...] Read More

FMEA Methodology As It Relates To The FDA And Medical Devices 

June 6th, 2014 by

FMEA for Medical DevicesAlthough it was originally developed for high-risk military [...] Read More

Instituting Effective FDA Gap Analysis Policies

April 25th, 2014 by

FDA Gap Analysis ComplianceWhen GxP firms take actions to maintain compliance with [...] Read More