MES reduces FDA compliance costs: medical device manufacturers face stringent regulations. Manufacturing Execution Systems can help reduce the cost of compliance.(Quality Software & Analysis )(Food and Drug Administration)

Quality, February, 2004 by Vinhais, Joseph

Medical device manufacturers, like manufacturers in other industries, must control costs, ensure product quality and shorten time-to-market. For the life science manufacturing industry, a noncompliant product or process does not simply result in expensive rework or customer dissatisfaction, it can cause illness, disablement, even fatality.

As a result, the U.S. Food and Drug Administration (FDA) requires that life science manufacturers meet stringent quality and manufacturing standards. The industry is guided by quality standards including a new FDA regulation, Regulation 21 CFR Part 820. Like ISO 13485, the International Organization for Standardization's quality assurance model for organizations that produce, install and service medical device products, 21...

Read the rest of this article with a Free Trial at HighBeam Research.

Premium Content Partnership | HighBeam Research provides an in-depth online archive library of reference works.