Blog

News

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 [...] 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 [...] Read More