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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

How Cybersecurity Impacts Device Producers

April 9th, 2015 by

Laptop & StethoscopeThe FDA can be slow to change its ways, but its guidelines aren’t immutable. As new technological concerns arise, the agency adapts its suggestions on how medical device manufacturers should respond, and [...] 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

How Do Medical Device Manufacturers Maintain Data Integrity?

April 2nd, 2015 by

Data IntegrityIs cybersecurity something you consider when designing a new product? As medical devices become more and more interconnected, the data they generate, store and share becomes more [...] Read More

Will 21 CFR 11 Hinder My Compliance Efforts?

March 31st, 2015 by

Electronic Records ManagementElectronic records are complex by nature. While they ostensibly serve as evidence of compliance efforts and regulatory adherence, [...] Read More

What Should Drive Your FDA Medical Device Compliance Efforts?

March 27th, 2015 by

Medical Device ComplianceHow do your compliance efforts impact the profitability of the goods you produce? Medical device manufacturers must comply with FDA standards to spread their products to as many markets as possible.

While [...] Read More

Deciphering EU Cybersecurity Plans and Policies

March 25th, 2015 by

Cyber SecurityBy default, your desire to market products in Europe makes EU cybersecurity compliance one of your primary organizational goals. Unfortunately, the path to effective regulatory adherence [...] 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