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Certification in ISO13485: 2003


Date: 13 Jan 2010

ISO 13485 is an ISO standard, published in 2003, represents the requirements for a comprehensive management system for the design and manufacture of medical devices. It focuses on risk management and design transfer activities during product development with specific requirements for inspection, traceability, documentation and validation of processes for the production of medical devices. This system also places specific requirements for verification of the effectiveness of corrective and preventive actions.