Medical Consumables Manufacturing

infusion, blood collection, filtration, connection, pipeline components and other types of medical consumables and accessories production.

OEM/ODM customized service

According to customer drawings, samples and technical requirements, to provide mold development, proofing, verification to mass production of one-stop service.

ISO13485

International Quality System Certification

ISO 13485 is an internationally recognized medical device quality management system standard and an important access basis for the global medical device industry. Weihai Kaibo Medical Devices has established a complete quality management system, and continues to optimize the whole process of quality control, from risk management, manufacturing to product traceability, to achieve full life cycle quality assurance, to ensure that products continue to meet domestic and foreign regulations and customer requirements. We always require ourselves to international standards to provide global customers with safer, stable and high-quality medical products.

FDA

an important guarantee of global market access

FDA registration is an important compliance requirement for medical devices to enter the US market, and it is also an important manifestation of the company's quality management capabilities and international operations. Weihai Kaibo medical devices strictly follow the relevant laws and regulations of the United States, continuously improve the quality management system and production process, ensure that the products meet the international market access standards in the process of design, manufacturing, testing and delivery, and provide more safe, reliable and stable medical device products for global customers.

Class 100,000

100,000 clean workshop

meets the standard of 100,000-level clean workshop, strictly controls the air cleanliness, temperature and humidity and microbial level in the production environment, and provides stable, safe and standardized production conditions for medical device manufacturing. Relying on the perfect clean production management system and advanced manufacturing equipment, we realize the whole process of clean control from raw materials, manufacturing, quality inspection to finished product packaging, and continuously guarantee the consistency, safety and reliability of products.