What is ISO 13485 and why is it so important?
The full Chinese name of ISO 13485 is “Medical Device Quality Management System - Requirements for Regulatory Purposes”. It is recognized as the highest-level quality management system standard in the global medical device industry. With strict regulatory compliance at its core, it covers the entire life cycle of medical devices from design and development, raw material procurement, production and manufacturing, warehousing and logistics to after-sales service, and imposes much stricter requirements on product quality, safety performance and risk management than ordinary industries.
For Bioecore, passing the ISO 13485 certification means:
• “Key” to international market access: The product quality and safety have been recognized by international authorities, which can meet the access requirements of major global markets;
• Compliance escorts the global development of products: A systematic and standardized quality management process has been established to minimize quality risks to the greatest extent;
• Enhance market competitiveness and consolidate the foundation of quality: It proves to customers, partners and regulatory authorities the enterprise’s ultimate pursuit of quality.
Focus on the development and manufacturing of biosensors, and carefully build core advantages
As a full-stack technology leading enterprise in the field of CGM (Continuous Glucose Monitoring), Bioecare has successfully empowered many domestic and foreign CGM enterprises, providing bioelectrodes, outer membrane materials, hardware and software technologies, intelligent manufacturing systems and R&D technical services. At present, Bioecare has successfully applied Physical Vapor Deposition (PVD) technology to the industrialization of bioelectrodes. Taking empowering and building the continuous glucose monitoring system (CGM) industry chain as a fulcrum, it focuses on the research and development of advanced manufacturing technology of bioelectrodes and polymer biomaterials, and is deeply engaged in the research, development, production and sales of wearable metabolic monitoring and physiotherapy rehabilitation medical devices.
Bioecare prototype: Bioecare-Lotus01-Continuous Glucose Monitoring System
Certification is not an end, but a higher starting point
Passing the ISO 13485 certification not only lays the foundation for Bioecare to enter the international market, but also enables us to align with international advanced levels in quality management. Cooperation with top domestic and foreign medical institutions and partners will be more competitive, and we will jointly promote the innovation and development of biosensor technology; the company will also form a quality management culture of continuous improvement, demanding itself with higher standards, and continuously improving product and service quality.
In the future, Bioecare will take the ISO 13485 certification as a new starting point, strictly abide by the system requirements, continuously strengthen the construction of the quality management system, keep improving in R&D innovation, production control, after-sales service, etc., protect life and health with safer and more reliable products, and contribute to promoting the development of the global biosensor industry.