ISO 13485 ISO 13485


Arguably, the most substantial success of the GHTF’s regulatory harmonization efforts has centered around the ISO 13485 standard, “Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes.”  This standard has been officially adopted by the European Union and Canada, as well as other countries representing smaller markets throughout the world, while Japan uses it as a base standard and supplements it with localized requirements where appropriate.  The US FDA claims that its Quality System Regulation (QSR) is harmonized with the 1996 version of this standard.


Regulations & Standards

 Document Description Comments
ISO 13485:2003 requirements are specific to medical devices and exclude some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, a firm’s quality management systems may conform to ISO 13485, but may not necessarily conform to ISO 9001.
CE Marking Before medical products can be placed on the European market, they must meet the requirements of the relevant European Economic Community product Directive. These Directives define product classification/requirements, certification, post-market monitoring, incident reporting and other CE Marking requirements. For more information:
A clause- by-clause comparison between the FDA QSR and 13485:2003 requirements prepared by Pilgrim Software.
Risk Management is considered essential for ensuring the safety and reliability of medical devices by both ISO 13485:2007 and the FDA QSR. ISO 14971 is specifically referenced within ISO 13485 and is recognized by the FDA as an acceptable risk management model.

Related Tools & Topics

 Document Description Comments
The Global Harmonization Task Force (GHTF) has assumed the leadership position for international harmonization in the regulation of medical devices. This site provides informative guidance on quality systems, auditing and risk management, among other topics.
Although the document is several years old, and has not been updated, it still provides an interesting overview of the global medical device market with respect to the top producers, consumers, emerging markets and evolving regulatory climate.
A fairly recent (2010) assessment of the medical device industry prepared by the US Department of Congress. It examines the global markets, including the role of the GHTF and upcoming changes to be introduced by the FDA.
PowerPoint presentation of ISO 14971:2007 made at the 11th Conference of the GHTF by the ISO/IEC Joint Working Group – provides overview and guidance for implementation.
A little-known, but very useful e-Handbook published online and jointly maintained by the US National Institute of Standards and Technology (NIST) and SEMATECH, a consortium of major semiconductor manufacturers, covering a great variety of statistical tools and techniques – including process control, sampling plans, design of experiments, etc.