Fangye has established a complete quality management system and strictly implemented and implemented it in production management. It has passed the ISO13485:2016 quality management system and product traceability system, and has the EU CE certificate and the US Food and Drug Administration's product listing (Listing) . With independent experimental process development and a professional laboratory, it can meet the entire process of Medical Consumables industry evaluation, verification and testing. And equipped with international standard 100,000-level purification workshop.
Product design, analysis
When we receive the customer’s drawings, samples or comments, we will immediately convene a new product development meeting organized by all relevant technical R&D personnel to analyze and evaluate its shortcomings and possible problems in the later production process. Based on our 16 years of industry experience, we can help customers effectively avoid the defects in the development of new products and give effective solutions and suggestions, such as appearance, material, production process, and product structure.
Mold development
After the new product design is completed and confirmed by the customer, our high-precision mold R&D workshop will process the mold according to the product design requirements. First, we use high-quality testing equipment to sample and test the steel to ensure that the quality of the raw steel is up to and in line Our requirements, followed by entering the mold processing process, each link and each processing detail has a special person to follow up and quality control, efficient mold development and production capacity and mold quality details to ensure that new products are developed from the mold The time to mass production of finished products does not exceed 45 days. The mature and experienced mold team can meet the production needs of different customers for the customized development of IVD consumables.
Mass production of new products
After the test mold is completed, the test model will be sent as soon as possible after confirmation by the customer for mass production. Runlan Technology covers an area of about 20,000 square meters. There are more than 50 injection molding machines and blow molding machines; automatic printing lines, packaging lines, and screwing There are more than a dozen capping machines, which can meet customers' various requirements for different processes and different output requirements. In the production process, Runlan has a strict quality control department, including daily first inspection, patrol inspection, random inspection, shipment inspection, including raw materials, product appearance, color, size, functional testing, etc., until the packaging is completed and sterilized. After shipment, the first batch of customized development consumables is delivered to the customer.
Fangye has advanced and rich industry experience, with full-process quality management control, and can provide global customers with customized development services for IVD consumables, including new product research and development, mold design and manufacturing, special professional customization, injection molding/blow molding production, and product inspection Efficient customization of the whole process.
For details, please contact: Disposable Medical Consumables.
