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ISO 13485

The medical device industry faces a complex global market place. Affected by multiple regulatory systems, international and national standards and requirements. This complex environment is dynamic, constantly changing, influenced by many national and international forums and initiatives, particularly the drive towards global harmonization.  Effective quality management systems like ISO 13485 are recognized as a key regulatory consideration for allowing medical device manufacturers to market their products around the world. The level of quality management system registration required will vary from market to market and dependent on the risks and hazards associated with the devices.

Whatever devices they produce medical device manufacturers have a responsibility to consistently deliver devices that are safe and effective.  

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 fulfillment 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.

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 13485:2003.  

On March 21, 2010, the EC Directive 2007/47/EC will become effective and have a big impact on the Directives 90/385/EEC and 93/42/EEC. All manufacturers declaring conformity of their products to either of these EC Directives should be aware of the following: Medical devices according to 90/385/EEC or 93/42/EEC must also comply with the new EC Directive starting March 21, 2010, otherwise the products cannot be placed on the European market.

All medical devices sold in the EU must have the CE Marking affixed to demonstrate compliance to this directive.

If your device falls within the scope of the Medical Devices Directive, then you must meet the essential requirements of that law. If you manufacture a Class I Sterile, Class I Measuring, IIa, IIb or Class III device, a Notified Body must be involved in the conformity assessment process to sell your product in the European Union. For Active Implantable Medical Devices, a Notified Body must be involved if your device falls within the scope of this Directive.

MOCG is uniquely positioned to interpret the global situation today and guide on the emerging requirements and regulations. Providing ISO 13485 services that help companies understand what they need to do to place, distribute and service compliant devices on markets through out the world.

Purchase the ISO 13485 Standard  (ISO 13485:2003: Medical devices Quality management systems Requirements for regulatory purposes)