Recently, Zhejiang Hengda New Materials successfully obtained the ISO13485:2016 Medical Devices Quality Management System certification. This significant milestone not only highlights Hengda New Materials' outstanding capabilities in product quality and management systems but also solidifies its position as a leading enterprise in China's medical paper field.

ISO13485:2016 – The Gold Standard in the Medical Device Industry

ISO 13485:2016 is an internationally recognized quality management system standard for the medical device industry. While based on ISO 9001, it more strictly focuses on quality control throughout the entire lifecycle of medical devices, from design and development to production, installation, and servicing. The core of this standard lies in ensuring the safety and effectiveness of medical devices. It rigorously requires companies to establish and implement a series of stringent quality control measures, including risk management, traceability, clinical evaluation, and post-market surveillance.

Hengda New Materials: Pioneer and Leader in China's Medical Paper Field.

Hengda New Materials stands as China's earliest-established, most technologically mature, and most diverse supplier of medical paper. Since its inception, the company has been dedicated to the research and production of specialty papers. Leveraging its robust technical strength, advanced production equipment, and stringent quality management system, Hengda has consistently held a dominant position in the mid-to-high-end market. Its products are widely applied in medical device packaging, earning widespread praise from both domestic and international clients for their stable performance and reliable quality. Hengda New Materials consistently upholds the business philosophy of "technological innovation, quality first," continuously driving industry advancements and contributing to the development of China's healthcare sector.

ISO 13485 Certification: Ushering in a New Era for Hengda New Materials

Achieving ISO 13485:2016 certification is profoundly significant for Hengda New Materials.
First, it signals that Hengda New Materials' medical paper products now fully comply with the highest international standards for medical device quality management systems. This significantly boosts the company's competitiveness in the global market, laying a solid foundation for expanding its worldwide operations.
Second, obtaining ISO 13485 certification further strengthens Hengda New Materials' quality management system. It drives the company to standardize and regulate every aspect, from product R&D and production process control to customer service. This ensures the continuous provision of safer, more reliable medical paper products to clients.
Finally, this certification also highlights Hengda New Materials' profound sense of responsibility for product quality and user safety. This isn't just a solemn commitment to existing customers; it will also attract the trust and cooperation of more medical device manufacturers, both domestically and internationally, collectively promoting the high-quality development of the healthcare industry.
Looking ahead, Hengda New Materials will continue to uphold its spirit of innovation and rigorous approach, constantly improving product quality and technological capabilities to write a new chapter in the company's development.