​​​​Who is ISO 13485 for?

ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related parts and services.  

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. 

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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.

 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.

Demonstrating safety and quality

​​​ISO 13485

Quality Management for Medical Devices

Locations in:         Alabama - California - Florida - Michigan - Minnesota - North Carolina - Washington - Wisconsin

Why was ISO 13485 revised?

ISO 13485:2016 is designed to respond to latest quality management system practices, including changes in technology and regulatory requirements and expectations.

What are the key improvements?

The new version has a greater emphasis on risk management and risk-based decision making, as well as changes related to the increased regulatory requirements for organizations in the supply chain.

What is ISO?

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