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ISO 13485 Quality Management System for Medical Devices
Certify your quality management system for medical devices with ISO 13485
ISO 13485 is a quality management system standard specifically for the medical devices industry, which encompasses aspects of the ISO 9001 standard, plus additional industry-specific medical device requirements.
ISO 13485 has been harmonized against the three EU Medical Devices Directives (Medical Devices, In-vitro Diagnostic Devices and Active Implantable Devices), so certification to this standard by an accredited certification body such as ECM automatically demonstrates compliance with specific clauses in these directives.
The certification of a quality management system, specifically for medical devices, to ISO 13485 proves advantageous, and in many cases essential, for medical companies which export their products to the global market.  In the European Union, the fulfilment of EU Directives (e.g., 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 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 example, Canada requires that medical device manufacturers marketing their products in Canada must have a quality system certified to ISO 13485.

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