On August 9th, Ruide New Material Technology (Foshan) Co., Ltd. officially passed the ISO 13485 Medical Devices Quality Management System Certification, earning international recognition for its professional strength and technological innovation in the field of medical materials.
ISO 13485 is the internationally recognized standard for medical device quality management systems, with stringent and comprehensive requirements that demand adherence to the highest quality standards and regulatory requirements at every stage, from product design, production, and sales to after-sales service.
This certification primarily covers the design and production of Ruide’s medical modified plastic particles. Ruide has successfully developed multiple medical-grade plastic compounds, including TPU/FEP/ETFE radiopaque materials and fluoropolymers for peelable tube.
Radiopaque TPU Compound
Radiopaque ETFE Compound
Fluoropolymer for Peelable Tube
Ruide understands that in the medical device industry, the quality of materials is closely related to the safety and effectiveness of the products. Therefore, the company continuously prioritizes innovation as its core driving force for development, consistently investing in research and development resources to optimize the formulations and production processes of plastic compounds, ensuring that they meet the stringent requirements for material performance, biocompatibility, and stability in the medical device industry. Additionally, the company has established a comprehensive quality management system and has strengthened employee training in quality awareness to ensure excellence in every detail and that each batch of products meets customer expectations for quality.
Looking to the future, Ruide will further optimize its quality management system, continuously enhance product competitiveness and service levels, and provide customers with safer, more reliable, and efficient material solutions, contributing more to the healthy development of the medical device industry.
