Quality Systems for Medical Devices - Sponsored Whitepaper

The voluntary 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 in the global market.

In the European Union, the fulfillment of EU Directives (e.g., Active Implantable Medical Device Directive, Medical Device 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 harmonized medical device quality system standard is ISO 13485. Consequently, certification demonstrates compliance with the quality system requirements of these EU Directives.

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 a new product in Canada, have a quality system certified to ISO 13485. TÜV is an SCC (Standards Council of Canada)-qualified ISO 13485 Registrar for the Canadian Medical Devices Regulations.

In the U.S., the revised Quality System Regulation (21 CFR 820, Oct. 7, 1996) was based upon the ISO 9001 and ISO 13485 quality system standards. U.S. manufacturers in compliance with the FDA Quality System Regulation can be confident that their quality system will, more than likely, meet the requirements of the ISO 9001 and ISO 13485 Standards. Certification by TÜV provides the third-party verification that your management system meets these requirements.