ISO13485 certification

The full name of ISO13485:2003 standard is 'Medical device Quality Management System for Regulatory requirements' (Medical device Quality Management System - Requirements for Regulatory). This standard is formulated by SCA/TC221 Technical Committee for Standardization of Medical Device Quality Management and General Requirements, and is an independent standard based on ISO9001:2000. The standard specifies the quality management system requirements for the relevant organizations, but it is not the ISO9001 standard in the medical device industry implementation guide.
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