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Getting Compliant With FDA 21 CFR Part 11

July 7th, 2014 by

FDA 21 CFR Part 11The FDA requires medical device manufacturers, pharmaceuticals manufacturers, biotech companies, biologic developers, and other FDA-regulated industries to comply with their regulations and implement controls.

These controls should also [...] 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

GxP-CC Earns ISO 9001:2008 Certification

May 8th, 2014 by

ISO 9001:2008 Certified IQNetGxP-CC has achieved ISO 9001:2008 certification. Developed by the International Organization for Standardization, ISO 9001:2008 is recognized as the worldwide standard for [...] Read More