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What Data Integrity Means to Device Manufacturers

August 28th, 2015 by

Data SecurityData integrity is an ever-increasing concern in life sciences, with medical device manufacturers feeling much of the conformity backlash. There continues to be heightened regulatory focus on diverse cybersecurity topics, including data integrity.

Public and private sector organizations [...] Read More

The European Medical Device Directive As It Compares To 21 CFR 820

March 10th, 2014 by

FDA & EU Medical Device ComplianceThe European Medical Device Directive or 93/42/EEC regulates which medical devices may be sold in the European market, while 21 CFR 820 is an FDA Quality Systems Regulation is a document that helps manufacturers of medical devices establish and follow a quality system within their [...] Read More