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ISO 13485:2016 Certification

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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.

The benefits of management systems certification:

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:

  • Expanded market access – National regulatory authorities require or strongly prefer that manufacturers marketing medical products in their countries have a third-party audited and certified management system in place. Investing in such a system speeds access into those countries that require it, and expedites market entry into the others.
  • Reduced cost of sales – Your certification establishes your company’s credibility and commitment to quality. Because the job of explaining the specifics and demonstrating the effectiveness of your quality system is more straightforward, it takes less time to earn your prospective customers’ faith and confidence.
  • Improved performance – Based on a uniform and widely-accepted system of process control, your company’s certified management system helps you improve your products and processes. This can foster improved relationships with your suppliers, customers, and business partners, and give you a real advantage in the marketplace.
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