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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

Deciphering the FDA Medical Device QSR

May 1st, 2015 by

Medical Device ManufacturingAs a medical device manufacturer, how do [...] Read More

How Compliant Are You with 21 CFR 210 / 211?

April 23rd, 2015 by

Pharmaceutical ManufacturingYou know which rules you’re [...] Read More

Medical Device Compliance: Recovering from FDA Warning Letters

April 21st, 2015 by

FDA Warning LetterYou’ve received one of the dreaded FDA Warning Letters. The last thing you want is to delay the launch of your company’s [...] Read More

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

April 7th, 2015 by

FDA Regulations[...] Read More

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

March 3rd, 2015 by

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

Good Pharmacovigilance Practices: Open the Doors to the EU

February 10th, 2015 by

EU Good Pharmacovigilance Practices[...] Read More

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

February 4th, 2015 by

EU Medical Device Cloud Computing Regulations[...] Read More