Founded in 2010, FLYPOWER is a high-tech enterprise specializing in the research, development, production, and sales of polymer materials. Leveraging its core technological strengths and starting with heat-shrink materials, the company established its Medical Division in 2018, expanding its business and product portfolio into the fields of medical devices and catheters, with the mission of becoming a globally leading supplier of materials for interventional medical devices.

联系我们 No. 77, Bao Nan Road,Nan Lian Community,Long Gang Street,Long Gang District, Shenzhen, Guangdong,518116,China (+86)755 2917 9250 [email protected]
重要信息
Quality Control

Full-Process Quality Control for Medical-Grade Assurance

The company strictly adheres to the requirements of medical device quality management regulations and the ISO 13485 quality management system, building a full-lifecycle quality control closed loop covering upstream raw material control, dynamic monitoring of the production process, multi-dimensional precision inspection of finished products, and protection during warehousing and delivery. Only globally compliant medical-grade brand resins are used as raw materials; each incoming batch undergoes sampling inspection of physical properties, extractables and biocompatibility. During production, key process parameters such as extrusion temperature, wall thickness and shrink ratio are locked in real time, with triple verification of first article, in-process patrol inspection and last article. Finished products undergo a full suite of tests including dimensional accuracy, mechanical properties, ethylene oxide residue and cytotoxicity; all test records are archived and retained, enabling complete batch traceability from raw materials to end use. Through systematic control, we ensure that every piece of medical heat shrink tubing and catheter tubing delivers stable performance and is safe and compliant for clinical use.
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Quality Control

We have successfully established a full-chain, multi-dimensional quality control system, with rigorous checks at every stage — from incoming raw material inspection and in-process inspection to precision inspection of finished products. Under stringent inspection standards, all key indicators are strictly controlled to ensure the stable, compliant performance of our medical tubing.

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Upstream Source Control

We carefully select and rigorously vet raw material suppliers of globally renowned brands. All incoming batches of raw materials must undergo strict, comprehensive physical property testing before entering our factory. We strictly adhere to quality principles and standards and rigorously guard the quality gate, ensuring a consistently stable and reliable source of supply.

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Process Control

We implement full-chain closed-loop process control: incoming materials pass strict inspection; each operation step is confirmed by first-article verification and real-time patrol inspection; semi-finished products are kept in segregated zones; finished products undergo full performance verification; all process data is documented and traceable — ensuring stable, reliable quality.

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Precision Inspection

Our quality laboratory is equipped with advanced testing instruments, enabling comprehensive testing of products in dimensional accuracy, mechanical properties and heat shrink performance. Every batch of products must pass strict final inspection before shipment.

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Traceability

We have established a comprehensive product traceability system. Raw material, process and inspection data are archived by batch; through the batch number, all process information can be traced in reverse. Quality issues can be quickly located and resolved in a closed-loop manner.

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Continuous Improvement

Leveraging the PDCA closed-loop management mechanism, we review and trace the entire process, quantify corrective actions and iteratively update control standards, continuously narrowing product variation and steadily improving the long-term reliability of medical tubing.