ISO 13485 certification leads to assurance to customers regarding safer production, the effectiveness of the quality management system of medical equipment and the fulfillment of legal requirements. The ISO 13485 standard in 2016 has replaced the previous edition standard ISO 13485:2003. Considering the importance of implementing ISO 13485 in ensuring the safety and effectiveness of the product, as well as the requirement of the General Directors of Medical Equipment and Devices (IMED) to implement, establishing and maintaining this standard is mandatory for domestic manufacturers. The implementation of ISO 13485 increases the organization’s commitment to the rules and requirements of the medical equipment quality management system and customer satisfaction.
AmirPayvand Research & Development Company, after conducting ISO 13485 external audit, received ISO 13485 certificate for general and molecular products that are awarded by BRS company as a valid ISO certified center in Iran and approved by IMED, and the products of this company are produced based on this certificate.
