ISO 13485, the Quality Management System for Medical Devices, is an international standard established with specific requirements for the medical device industry, building on the ISO 9001 International Quality Management System. In today’s rapidly evolving medical technology landscape, the quality and safety of medical devices have become a global focus. ISO 13485 certification serves as a seal of approval in the medical device industry, playing a critical role in improving product quality and ensuring patient safety. Sunrise Metal is a high precision injection molding manufacturer certified to ISO 13485, which means we meet the highest standards of quality and safety within the medical device industry. Choose us as your trusted partner.
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