Certificates & Compliance
Our commitment to quality, safety, and regulatory compliance
Quality Assurance
At Nuohong Bio, we are committed to maintaining the highest standards of quality and compliance. Our products are manufactured under strict quality control procedures to ensure they meet international standards and regulatory requirements.
Our comprehensive quality management system is certified to ISO 9001:2015 and ISO 13485:2016 standards, demonstrating our commitment to consistently providing products that meet customer and regulatory requirements.
We also maintain various other certifications and registrations, including CE Marking, FDA Registration, and GMP Compliance, ensuring that our products can be confidently used in regulated environments worldwide.
Compliant Products
Major Certifications
Countries Served
Years of Excellence
Our Certifications
ISO 9001:2015
Quality Management System Certification
ISO 13485:2016
Medical Devices Quality Management System
CE Marking
European Conformity for Safety, Health, and Environmental Protection
FDA Registration
U.S. Food and Drug Administration Registration
GMP Compliance
Good Manufacturing Practice Compliance
Environmental Management
ISO 14001:2015 Environmental Management System
Compliance Standards
Quality Management
- ISO 9001:2015 Quality Management System
- ISO 13485:2016 Medical Devices Quality Management System
- Good Manufacturing Practice (GMP) Compliance
- Quality Control Testing Standards
Product Safety
- CE Marking for European Economic Area
- FDA Registration for US Market
- Biocompatibility Testing (ISO 10993)
- USP Class VI Testing where applicable
Quality Control Process
Our rigorous testing ensures product reliability and consistency
Raw Material Inspection
All incoming materials are thoroughly tested for compliance with specifications.
In-Process Controls
Multiple checkpoints during manufacturing ensure quality at every stage.
Final Product Testing
Comprehensive testing of finished products to verify specifications and performance.
Batch Traceability
Complete traceability system for all products from raw materials to customer delivery.
Need More Information?
Contact our quality assurance team for detailed information about our certifications and compliance.
Contact Us