ISO 13485 is an International Organization for Standardization (ISO) standard, published in 2003, that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. Compliance with ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements. The conformity of Medical Devices and In-vitro Diagnostic Medical Device according to European Union Directives 93/42/EEC, 90/385/EEC and 98/79/EEC must be assessed before sale is permitted. The preferred method to prove conformity is the certification of the Quality Management System according ISO 9001 and/or ISO 13485 and ISO 14971 by a Notified Body. The result of a positive assessment is the certificate of conformity allowing the CE mark and the permission to sell the medical device in the European Union. ,