Quality & Certifications
Quality is embedded in our process. We maintain structured documentation, verification steps, and continuous improvement practices aligned with certification requirements and partner expectations.
Quality is Embedded in Our Process
According to ISO13485 quality management system and EU CE certification requirements, we have invested significant resources to build production lines and design process flows, constructed a 100,000 level purification workshop of 5,000 square meters.
Our facilities include an advanced laboratory system, microbiology laboratory, sterile room, and are equipped with a large number of advanced testing instruments.
On the basis of production management MDR and ISO13485 in our own factories, all of our protective products pass CE certification. Our products have been exported globally to Europe, Asia, America, and beyond.
Our Quality Pillars
The foundation of our commitment to excellence in healthcare products.
Structured Documentation
Comprehensive documentation practices ensuring full traceability across all operations and processes.
Verification Steps
Multi-stage verification protocols at every step of production to ensure product integrity.
Continuous Improvement
Ongoing assessment and enhancement of processes aligned with partner expectations.
Advanced Testing
State-of-the-art laboratory facilities for comprehensive quality testing and analysis.
Compliance First
Strict adherence to international regulatory guidelines and industry standards.
Audit Ready
Always prepared for regulatory audits with complete documentation and traceability.
Our Certifications
Internationally recognized certifications validating our commitment to quality and safety.
ISO 13485:2016
Quality Management System for Medical Devices
CE — Medical Masks
European Conformity · EN 14683 (Type I / II / IIR)
CE — Surgical Gowns
European Conformity · EN 13795 protective apparel
CE — Protective Coveralls
European Conformity · EN 14126 (PPE Category III)
Official certificates and test reports are available on request. Contact our team to receive the current documentation for a specific product or standard.
Manufacturing Excellence
State-of-the-art facilities designed for quality and scale.
5,000 sqm
Purification Workshop
100,000 Class
Cleanliness Level
1,000,000+ units
Daily PPE Capacity
50+
Export Countries