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ISO 13485:2003 

ISO 13485 specifies requirements for a quality management system for medical devices and related services that demonstrates consistency and facilitates the harmonization of medical device regulatory requirements. ISO 13485 provides for controls in the work environment to ensure product safety, focuses on risk management activities and design transfer activities during product development and specifies requirements for verification of the effectiveness of corrective and preventive actions.

For more information contact us at: isoinfo@iapmort.org or 1-877-4MYISO1 (469-4761)