Recently, Shenzhen Zuowei tech successfully passed the ISO13485:2016 medical device quality management system certification, it means that the company’s quality management system has reached international standards and regulatory requirements.
ISO13485 is the most authoritative international quality system standard in the medical device industry, and its full Chinese name is “Medical Device Quality Management System for Regulation Requirements”, which is an independent international standard developed by the International Organization for Standardization (ISO) and applicable to the medical device industry. ISO13485 is based on ISO9000 and add some special requirements for the medical device industry, which is strict requirements in product identification, process control and other aspects.
Shenzhen Zuowei has always focus on the product development, production and quality control as the top priority, Passed the ISO13485 , marking that our company’s products in quality control is in the international standards, further demonstrate the company’s strength to provide global medical device customers with technology and technical product services, for the company’s development in the field of medical devices laid a new foundation.
Previously, our company’s products have passed the US FDA registration, EU MDR registration and CE certification. Those certifications are a reflection of the company’s R & D and innovation strength, product quality system and comprehensive strength, which will surely promote a more wonderful posture as a science and technology in the international arena!
In the future, Shenzhen Zuowei will take this certification as an opportunity, strictly in accordance with the quality management system standards, continue to guarantee based on refined management, constantly improve internal quality control, continuously improve service levels, and provide better products and technical services for our customers.
Post time: Mar-17-2023
