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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

Is Seeking Outside Consulting Advantageous In The Medical Device Industry?

February 11th, 2014 by

Supply Chain ManagementThe manufacture and sale of medical devices, be they intravenous catheters or operating tables, is a highly complex undertaking requiring a deft balancing of FDA regulatory concerns with ambitious output [...] Read More