ISO 13485- Business Directory
As it is a sector largely treated worldwide law, is a fundamental objective of ISO 13485 harmonize the legal requirements of the quality management systems of medical devices. ISO 13485 is a standard which is based on ISO 9001, but includes some particular requirements for medical devices such as: risk analysis, sterile manufacturing and Traceability. Standard omits some of the requirements of ISO 9001 that are not necessary as legal requirements. Because of these gaps can not be an organization certified to ISO 13485 compliance with ISO 9001.
Continuity of legal requirements for approval of medical devices.
For manufacturers of medical devices is a fundamental legal approach to product market. National regulations often refer to the ISO 13485 and require it as part of the approval process for medical devices, such as the EU Directive on medical devices (Directive on medical devices 93/42 / EEC, Directive diagnostic agents in vitro 98/79 / EC, Active implantable medical devices 90/385 / EEC). The company DNV is also appointed by the notified bodies on the implementation of the conformity assessment under Annex II, IV and V of the Directive medical devices 93/42 / EEC. Manufacturers certified according to ISO 13485: 2003 fulfill the requirements for a quality management system in all classes of this Directive.