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Outsourcing and the Device Manufacturer’s QMS Accountability

August 6th, 2015 by

Global Medical Technology ComplianceIn 2003, the International Organization for Standardization (ISO) issued ISO 13485, officially known as EN ISO 13485:2003. This voluntary international standard provides a framework to assist medical [...] 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 apply to finished devices, that are intended for human use.. Rather than impose strict requirements, the regulations offer manufacturers of these devices an opportunity to [...] Read More

Anticipating FDA Initiatives for Risk Management

May 6th, 2015 by

Guidelines Rules and ComplianceRegulatory bodies like the FDA enact initiatives on a routine basis. While their timing [...] Read More

Deciphering the FDA Medical Device QSR

May 1st, 2015 by

Medical Device ManufacturingAs a medical device manufacturer, how do you identify your compliance obligations? Companies that want to fulfill their duties properly generally look to FDA 21 CFR 820, the Quality System Regulation and the 21 CFR 800 series of [...] Read More

How Compliant Are You with 21 CFR 210 / 211?

April 23rd, 2015 by

Pharmaceutical ManufacturingYou know which rules you’re responsible for following, but is that enough? Agencies like the FDA rarely make exceptions for firms that misinterpret the law, and although you may be able [...] 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 RegulationsPharmaceutical manufacturers can’t sell their products without first convincing regulators of their safety. Firms that fail to do so sustain fiscal losses when they [...] 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 Training Program in San Diego, CA, including a Train-the-Trainer session. The training entailed all aspects of regulatory requirements and perspectives concerning Data Integrity in the Life [...] Read More

Good Pharmacovigilance Practices: Open the Doors to the EU

February 10th, 2015 by

EU Good Pharmacovigilance PracticesThe pharmaceuticals you manufacture have massive potential. On one hand, they could represent a vital cure for struggling patients, but they [...] Read More

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

February 4th, 2015 by

EU Medical Device Cloud Computing RegulationsCloud computing architectures vary widely. In addition to incorporating tons of different device types, they also use diverse routing, layer networking and messaging protocols. These essential variances [...] Read More