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ISO 13485: 2016 is a global standard that is represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. The certification of a quality management system, specifically for medical devices, to ISO 13485 proves beneficial, and in many cases essential, for medical companies which export their products to the international market. In the European Union, the fulfillment of EU Directives (like Active Implantable Medical Devices Directive, Medical Devices Directive and In Vitro Diagnostic Directive) allows the free trade of medical devices. A significant portion of demonstrating compliance with the EU directive requirements is the establishment and independent assessment of the quality system.
The European standard EN ISO 13485:2016 Medical Devices, Quality Management Systems, Requirements for Regulatory Purposes, has been published, after approval by CEN on 24 February 2016. This replaces EN ISO 13485: 2016. The modification was made as a number of European countries objected to the inference that ISO 13485 inferred compliance to the Medical Device Directive (MDD). To solve this problem, annexes at the beginning of the new standard have now been expanded to link the clauses of ISO 13485 to the Medical Device Directive.
The current European medical device quality system standard is EN ISO 13485:2016. When manufacturers are active in the world market, the focus on global or international standards (e.g. ISO) is not only advantageous - it may be stipulated by certain countries. For instance, Canada requires that medical device manufacturers marketing their products in Canada must have a quality system certified to ISO 13485:2016.
Your management system’s conformity with ISO 9001, ISO 13485, or ISO14001 can help your company open doors to untapped national and global business opportunities, and reap the benefits of: