Specialty

estrong醫強大樓外觀

Quality Management System

Adhering to the international standards of GMP & ISO 13485, from raw materials, finished products, storage environment to clean room production, all are strictly checked and controlled to provide stable, safe and effective products.

 

 

International Standard

GMP & ISO 13485

International Quality Assurance Certification

Environmental Control

Air conditioning and water system monitoring

Continuous Improvement

BenQ Continuous Improvement Project CIP

 

 

Safety and effectiveness

196 product inspections

 

Inspection Items

196 Inspections
Raw Material Inspection

Material specification measurement, hollow fiber membrane analysis, cleanliness inspection.

Environmental Water Quality Inspection

Regularly airborne microbe inspection, process water microbe and endotoxin inspection.

Process Inspection Items

Laser sintering inspection, section inspection, AOI automatic optical inspection,package assembly integrity test , leak testing.

Product Testing

Finished product performance testing, endotoxin testing, bioburden testing, sterilization dose monitoring.

 

Milestones

Quality Certification