Quality Management System
At Roosin Medical, quality is the cornerstone of our commitment to global healthcare. Since our founding in 1996, we have established a robust Quality Management System (QMS) that integrates scientific innovation with rigorous compliance.
Manufacturing Excellence
Our production is conducted in a 30,000 SQM facility, featuring a Class 100,000 (ISO Class 8) clean workshop to ensure the highest standards of hygiene and safety for medical device manufacturing.
Traceability
We implement a comprehensive traceability system that monitors the entire product lifecycle-from raw material procurement to final delivery-ensuring every batch meets documented specifications.
Sterile Production Control
Utilizing advanced sterilization technology and environmental monitoring, we guarantee the sterility and integrity of our wound care solutions, protecting patients across 87 countries.
International Certifications
Roosin Medical adheres to the most stringent international regulatory requirements. Our products are certified for safety and efficacy by leading global health authorities.
Our Regulatory Portfolio Includes:
Stringent Quality Control Process
We employ a multi-stage Quality Control (QC) protocol to ensure zero-defect manufacturing and clinical reliability.
Incoming Inspection (IQC): Rigorous testing of all raw materials and components against technical specifications before they enter the production line.
In-Process Inspection (IPQC): Continuous monitoring and real-time testing during the manufacturing phase to maintain process stability and product uniformity.
Final Inspection (FQC/OQC): Comprehensive performance testing and packaging integrity checks on finished goods to ensure every product arriving at a medical facility is ready for clinical use.