ISO 13485 is the ISO 9000 for medical device manufacturers. Embracing the FDA’s good manufacturing practices, this standard defines terms such as: medical device, active medical device, active implanted medical device, sterile medical device, and more.

This international standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

The primary objective of this standard is to facilitate harmonized medical device regulatory requirements for quality management systems. It includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.

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