April 21, 2026 — Rayboen successfully held the kick-off meeting for the ISO 13485:2016 Medical Device Quality Management System Certification Project. Attended by the company’s senior management team, department leaders and key core employees, the meeting marks a pivotal step forward for Rayboen in medical compliance, quality control and global development strategy.
Key Highlights of the Meeting
The meeting officially announced the full implementation of the ISO 13485:2016 international standard, aiming to establish a professional medical device quality management system that covers the entire process: design and development, procurement and supply, production and manufacturing, quality control, packaging and delivery, as well as after-sales service.
The meeting clarified project goals, implementation plans, role division and schedule milestones. It emphasized taking risk management as the core, regulatory compliance as the bottom line, and quality as the top priority, integrating system requirements into daily operations in depth to ensure product safety, efficacy and traceability.
The launch of this certification not only realizes a systematic upgrade of the existing quality management system, but also serves as a strategic layout for the company to deepen its footprint in the medical industry and expand global business.
About ISO 13485:2016
ISO 13485:2016 is a dedicated quality management system standard for the medical device industry issued by the International Organization for Standardization (ISO). It focuses on regulatory compliance, risk management and full life cycle quality control, and is widely applicable to enterprises engaged in the design, production and service of medical devices, supporting components and consumables.
This standard has become the core market access requirement and credibility benchmark for global regulatory authorities including EU MDR, US FDA QSR and China NMPA, as well as international customers worldwide.
The initiation of ISO 13485:2016 certification is an important milestone in the company’s development. In the future, Rayboen will take the system establishment as an opportunity to continuously optimize processes, strictly control product quality and strengthen compliance management. The company strives to obtain the certification as soon as possible, repay customers with higher-standard products and services, and contribute to the development of the global healthcare industry.
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