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Premarket Submissions of Medical Devices

March 11th, 2016 by

Medical DevicesIn a recent quarterly 2015 report, the US Food and Drug Administration (FDA) stated that major [...] Read More

Key Characteristics of FDA Part 11 Compliance

February 4th, 2016 by

Ultrasound Properly managing sensitive information to maintain privacy and security has become paramount in recent years. Today, [...] Read More

10 CAPA Tips for the Medical Device Industry

January 27th, 2016 by

Male Scientist Using Medical ToolsThe CAPA process from the side of regulatory compliance [...] Read More

How to Avoid Pharmaceutical Data Integrity Issues

January 22nd, 2016 by

Pharmacists in LabIn 2015, the US Food and Drug Administration (USFDA) issued Warning [...] Read More