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How Compliant Are You with 21 CFR 210 / 211?

April 23rd, 2015 by Zuhdi Hussein

You know which rules [...] Read More

Posted in General, Comments Feed: RSS 2.0

Tags: 21 CFR 210 / 211 Compliance, FDA Quality Management System Compliance, GxP CC, 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 is to delay the launch of your [...] Read More

Posted in FDA & European Regulations, Comments Feed: RSS 2.0

Tags: FDA Warning Letters, Form 483, GxP CC, Medical Device Compliance

How Cybersecurity Impacts Device Producers

April 9th, 2015 by James Francum

The FDA can [...] Read More

Posted in FDA & European Regulations, Comments Feed: RSS 2.0

Tags: Cybersecurity, FDA Regulated Medical Devices, management of cybersecurity in medical devices, quality management devices

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

April 7th, 2015 by Zuhdi Hussein

FDA Regulations [...] Read More

Posted in FDA & European Regulations, Comments Feed: RSS 2.0

Tags: compliance consulting, FDA Benefit Risk Assessment, FDA Drug Approval Process, GMP Manufacturing Processes, GxP CC, PDUFA, Prescription Drug Users Fee Act

How Do Medical Device Manufacturers Maintain Data Integrity?

April 2nd, 2015 by Henry Macartney

Data Integrity [...] Read More

Posted in FDA & European Regulations, Comments Feed: RSS 2.0