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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

How Cybersecurity Impacts Device Producers

April 9th, 2015 by James Francum

The FDA can be slow to change its ways, but its guidelines aren't immutable. As. [...] Read More

Posted in quality management devices

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

How Do Medical Device Manufacturers Maintain Data Integrity?

April 2nd, 2015 by Henry Macartney

Is cybersecurity something you consider when designing a new product? As. [...] Read More

Posted in FDA & European Regulations

Will 21 CFR 11 Hinder My Compliance Efforts?

March 31st, 2015 by James Francum

Electronic records are complex by nature. While they ostensibly serve as. [...] Read More

Posted in FDA regulations

What Should Drive Your FDA Medical Device Compliance Efforts?

March 27th, 2015 by Zuhdi Hussein

How do your compliance efforts impact the profitability of the goods you. [...] Read More

Posted in FDA Medical Device Compliance

Deciphering EU Cybersecurity Plans and Policies

March 25th, 2015 by Henry Macartney

By default, your desire to market products in Europe makes EU cybersecurity. [...] Read More

Posted in governance techniques

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

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