ISO 13485 certification ensures customers of safer production, the effectiveness of the medical device quality management system, and compliance with legal requirements. The ISO 13485 standard was updated in 2016, replacing the previous edition, ISO 13485:2003. Considering the importance of implementing ISO 13485 in ensuring product safety and effectiveness, as well as the requirement of the General Administration of Medical Equipment for domestic manufacturers, the implementation, establishment, and maintenance of this standard is mandatory. Implementing ISO 13485 increases the organization’s commitment to medical device quality management system regulations and requirements, and enhances customer satisfaction.
After undergoing an external ISO 13485 audit, the knowledge-based company ap-rad received the ISO 13485 certification for its manufactured general and molecular products from BRS, a reputable ISO certification body in Iran approved by the General Administration of Medical Equipment. The company’s products are manufactured based on this certification.
