ISO 13485 MEDICAL DEVICES –QUALITY MANAGEMENT SYSTEMS
ISO 13485 standard was created based on the ISO 9001 standard, it is an international standard which contains specific requirements for Medical Devices. ISO 13485 is a system which is necessary for establishing firms which prefer H module in the frame of CE marking and which will be used by Medical Device maufacturers during the CE marking procedure. Basically, including ISO 9001 Quality Management System it has been turned into a standard which belong to medical device manufacturers who have additional wishes and requirements especially on the level of design.
ISO 13485 is a standard that defines specific conditions which quality systems focused on organizations that are active in the field of trading and manufacturing medical devices should provide and which will all organizations that include medical devices or services related to them, for example project, production, installation services and procurement may be applied.