The ISO 13485 standard is based on the ISO 9001 process model approach and is a management systems standard specifically designed for the manufacture of medical devices and equipment.
ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. This is consistent with the design, development, manufacture, installation and delivery of medical devices that are safe for their intended purposes.
Obtaining the ISO 13485 certificate is a requirement of the General Directorate of Medical Equipment of the Islamic Republic of Iran to obtain an activity license under the supervision of IMED, so all manufacturers and importers of medical equipment must implement ISO 13485 consultation and obtain ISO 13485 certification. ISO13485 certificate should be obtained from the list of CB certification companies trusted by IMED. This list is constantly changing, so it is recommended to consult with our advisors in the management of the ISO 13485 certification company to save your time and money significantly.
