International Regulations and Standards

The World Health Organization, especially the European Office in Copenhagen, has become increasingly involved in medical devices, especially promoting the idea of international exchange of information. International cooperation and communication could make much more information on medical equipment available and save evaluation resources of all countries. A harmonized description/structure of planning documentation will be provided to ensure comparisons between European countries. The International Standards Organization (ISO) was established in 1947 and its members are drawn from the national standards bodies of its members. ISO is responsible for standardization in general, but with the exception of electrical and electronic standards which are the responsibility of the International Electrotechnical Committee (IEC). International organizations have developed regulations and guidelines for software and software controlled devices. For example, ISO 9000-3 specifically addresses software development in addition to what is contained in ISO 9001.