The International Organization for Standardization has developed more than 17,000 international standards on numerous subjects. For medical device companies, the most important of these standards is ISO 13485, which provides internationally recognized guidelines pertaining to quality management systems (QMS). Certification to ISO 13485 doesn’t necessarily fulfill the requirements of regulatory agencies such as the U.S. Food and Drug Administration (FDA), but it will bring a company’s QMS in line with the FDA’s quality system regulation (QSR) standards.

The benefits of ISO 13485 certification are numerous: increased efficiency, cost savings, more effective risk management and quality assurance, and an improved ability to respond to customer requirements are just a few of the potential results that certification to the standard can bring. There are four key activities that your company can undertake to prepare for ISO 13485 certification and ultimately enjoy such benefits.

1. Identify the basic ISO 13485 requirements and how they apply to your business. Because the needs of medical device manufacturers are as varied as the needs of regulatory agencies, the ISO 13485 guidelines have been written so as to present specific medical device requirements in a generic framework.

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