In August, Suzhou Silver Mars New Materials Technology Co., Ltd. successfully obtained certification for the GB/T 42061-2022 / ISO 13485:2016 Medical Device Quality Management System. This achievement marks a significant milestone in the company’s development, particularly in product research, development, and quality control.
The GB/T 42061-2022 / ISO 13485:2016 standard, Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes, is designed to ensure standardized procedures throughout the entire lifecycle of medical devices—including design, development, production, and post-market service—ensuring both safety and effectiveness.
This successful certification further strengthens Suzhou SilverMars' commitment to standardization, streamlined processes, and systematic quality management, laying a solid foundation for the company’s future growth and long-term success in the medical device industry.
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