Through the 1990s, the application of a quality system relied primarily upon the Food and Drug Administrations’ (FDA) good manufacturing practice requirements or the FDA 21 CFR Part 820 Quality System Regulation. At that time, the international standards for quality management systems (QMS) were ISO 9001, ISO 9002, or ISO 9003, depending upon the scope of the organization’s quality system. Fast forward to 2009 and in the medical devices manufacturing industry, we now rely primarily upon ISO 13485 and the FDA Part 820 Quality System Regulation (QSR) to assure compliance. ISO 13485 and the quality system regulation are the de facto standards utilized by medical device and in vitro diagnostic companies for compliance with QMS requirements. There are other regulatory standards that may be specific to regions or countries that must be reviewed separately for organizations specific needs.

In this article, we will discuss how to utilize these standards for assuring harmonized compliance and assist in marketing devices around the world. We will focus primarily on ISO 13485—"Medical devices—Quality management system—Requirements for regulatory purposes," and how this international standard is utilized for meeting global regulatory requirements.

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