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Outsourcing and the Device Manufacturer’s QMS Accountability

August 6th, 2015 by

Global Medical Technology ComplianceIn 2003, the International Organization for Standardization (ISO) issued ISO 13485, officially known as EN ISO 13485:2003. This voluntary international standard provides a framework to assist medical [...] Read More

Deciphering the FDA Medical Device QSR

May 1st, 2015 by

Medical Device ManufacturingAs a medical device manufacturer, how do you identify your compliance obligations? Companies that want to fulfill their duties properly generally look to FDA 21 CFR 820, the Quality System Regulation and the 21 CFR 800 series of [...] 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 assessments, Failure Mode and Effects Analysis (FMEA) methodology has become essential for medical device manufacturers. Firms that want to market products intended for human use must provide some assurance that these [...] Read More

Instituting Effective FDA Gap Analysis Policies

April 25th, 2014 by

FDA Gap Analysis ComplianceWhen GxP firms take actions to maintain compliance with recommendations from the FDA and the EU, it’s critical that they actually analyze the results after the fact. Failing to assess your compliance implementations effectively and on a periodic basis could [...] Read More