We have established a research and development team of senior experts with more than ten years of balloon manufacturing and research experience. It has obtained research and development capabilities essential for product development, from material molecules, process treatment, methodology, product production, and quality control to clinical research. Through in-house research or outside cooperation, we have developed a number of interventional medical products that address the clinical pain points of Chinese patients. Our products have covered many TAs, such as vascular intervention and hemodialysis access.
Since August 3, 2011, Polyrey Medical has maintained a sound quality management system following the requirements of GMP, ISO13,485, and MDD
We have obtained three domestic registration certificates for Class III medical devices and one CE certificate. Since the launch of the products, we have strictly followed the requirements of quality management system, adhered to the principle of "patients’ health first", and paid close attention to product design and development. We have a group of highly responsible quality inspectors, and high-end instruments such as liquid chromatograph, water pressure tester, image measuring instrument to strictly control product quality.
Our products passed the national sampling quality inspection in 2017, the unannounced audits by the CE notified body in April 2019, and the post marketing evaluation and inspection by Jiangsu Drug Administration in September 2021. In addition to regular internal audit, we undergo the annual on-site inspection conducted by the Drug Administration. Our products and quality management system are under orderly control.
0512-69568906
201, Building C9, No. 218, Xinghu Street, Suzhou Industrial Park