The global demand for medical devices has been steady in traditional markets despite the economic downturn and even increasing in some emerging markets. For medical device manufacturers seeking access to new markets, conformity with regulatory requirements is most often a prerequisite. Those who want to compete effectively should also have in place a properly implemented and maintained quality management system.

Many manufacturers are discovering the benefits of working with a registrar because their experience and know-how provides a single source for certification to international standards and conformity assessments to medical device directives.

The benefits of management systems certification

For example, your management system’s conformity with ISO 13485—“Medical devices—Quality management systems—Requirements for regulatory purposes,” from the International Organization for Standardization (ISO) can help you open the door to untapped domestic and international business opportunities, and reap the benefits of:

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