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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 of [...] 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

What Data Integrity Means to Device Manufacturers

August 28th, 2015 by

Data SecurityData integrity is an ever-increasing concern in life sciences, with medical device manufacturers feeling much of the [...] Read More

The EU Influence on Medical Devices & Their Manufacture

August 20th, 2015 by

Surgical Scissors Medical Device[...] Read More

Complying with eMDR FDA Regulations

August 14th, 2015 by

Medical Lab TechnicianIn February of 2014 [...] Read More

Outsourcing and the Device Manufacturer’s QMS Accountability

August 6th, 2015 by

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

A Flexible Approach to 21 CFR 820 Compliance

June 11th, 2015 by

Medical Device ComplianceThe Quality Systems (QS) Regulations of FDA 21 CFR 820 are general standards that [...] Read More

Anticipating FDA Initiatives for Risk Management

May 6th, 2015 by

Guidelines Rules and Compliance[...] Read More