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Outsourcing and the Device Manufacturer’s QMS Accountability

August 6th, 2015 by Henry Macartney

In 2003, the International Organization for Standardization (ISO) issued ISO. [...] Read More

Posted in Medical Device Quality Management Systems

A Flexible Approach to 21 CFR 820 Compliance

June 11th, 2015 by Henry Macartney

The Quality Systems (QS) Regulations of FDA 21 CFR 820 are general standards. [...] Read More

Posted in Quality Systems Regulations

Anticipating FDA Initiatives for Risk Management

May 6th, 2015 by James Francum

Regulatory bodies like the FDA enact initiatives on a routine basis. While. [...] Read More

Posted in Risk Management

Deciphering the FDA Medical Device QSR

May 1st, 2015 by Henry Macartney

As a medical device manufacturer, how do you identify your compliance. [...] Read More

Posted in Quality System Regulation

How Compliant Are You with 21 CFR 210 / 211?

April 23rd, 2015 by Zuhdi Hussein

You know which rules you're responsible for following, but is that enough?. [...] Read More

Posted in supplier audits

Medical Device Compliance: Recovering from FDA Warning Letters

April 21st, 2015 by Henry Macartney

You've received one of the dreaded FDA Warning Letters. The last thing you want. [...] Read More

Posted in Medical Device Compliance

The Role of FDA Benefit-Risk Assessment in Regulatory Decision Making

April 7th, 2015 by Zuhdi Hussein

Pharmaceutical manufacturers can't sell their products without first convincing. [...] Read More

Posted in Prescription Drug Users Fee Act

GxP-CC Completes GMQA's Electronic Data Integrity Certification Training

March 3rd, 2015 by James Francum

Team members of GxP-CC consultants have completed the full session of the Data. [...] Read More

Posted in Monica Cahilly

Good Pharmacovigilance Practices: Open the Doors to the EU

February 10th, 2015 by James Francum

The pharmaceuticals you manufacture have massive potential. On one hand, they. [...] Read More

Posted in GxP CC

How Compliant Are Your Medical Devices with EU Cloud Computing Regulations?

February 4th, 2015 by Zuhdi Hussein

Cloud computing architectures vary widely. In addition to incorporating tons of. [...] Read More

Posted in Medical Device EU Guidelines

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