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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

FDA 21 CFR Compliance as a Gateway to Market Viability

January 27th, 2014 by

FDA 21 CFR RegulationBefore selling their products, firms have to ensure that they adhere to US and European government regulations. This is a job in and of itself; staff at all levels must maintain extensive conversance with a huge body of rules devised by the Food and Drug Administration (FDA) and other regulatory bodies.

For specialized companies trying to stay legal, such a herculean task is practically impossible without outside assistance, when one considers the restrictions that [...] Read More