济南Good News! Yuanke Henghui Technology Co., Ltd. Passes EN ISO13485 + EN ISO11137 Medical Device Irradiation Sterilization Quality Management System Certification!

Recently, Yuanke Henghui Technology Co., Ltd. successfully obtained ISO13485 and ISO11137 certifications for its medical device irradiation sterilization quality management system. This achievement signifies that our company has established a scientifically sound and internationally compliant quality management system for medical device irradiation sterilization, enabling us to provide high-quality sterilization services to both domestic and international medical device clients.

ISO13485 is the most authoritative international quality system standard in the medical device industry. It builds upon ISO9001 by adding specific requirements tailored to medical devices, including stricter controls related to product labeling and process management. ISO11137, on the other hand, is the international standard for radiation sterilization of healthcare products, outlining requirements for the radiation sterilization process and quality control of medical devices.

Currently, Yuanke Henghui Technology Co., Ltd. holds ISO13485 + ISO11137 dual certifications, covering comprehensive quality control throughout the entire irradiation sterilization process, across various stages and multiple product lines. This achievement enhances our overall capabilities in providing irradiation sterilization services for medical devices, food, pharmaceutical materials, and hygiene products. We will leverage this milestone to maintain fine-tuned, systematic, and standardized management practices, consistently adhering to high-quality management system standards. Our commitment is to deliver top-notch irradiation technology services and establish a positive corporate image and reputation in the competitive market. ��