International Standards

International Standards

Globally compliant products

Quality First

Quality First

Strict quality controlin every step

Full Traceability

Full Traceability

Batch traceabilityand UDI support

Customer Trust

Customer Trust

Long-term reliabilityand partnership

INTERNATIONAL COMPLIANCE STANDARDS

CE / MDR

CE / MDR

Compliant withEU MDR requirements

DIN 13164

DIN 13164

Compliant with DIN 13164 standard forautomotive first aid kits

ISO 13485

ISO 13485

Certified quality management system for medical devices

FDA Registration

FDA Registration

Support forU.S. market access

BSCI

BSCI

Audited social compliance standards

UDI Labeling

UDI Labeling

UDI labeling and product traceability support

QUALITY CONTROL PROCESS

Incoming  Inspection

Incoming Inspection

Rawmaterials
inspection

Incoming  Inspection
Assembly Verification

Assembly Verification

In-process quality verification

Assembly Verification
BatchTraceability

BatchTraceability

Lot tracking and traceabilitysystem

BatchTraceability
FinalInspection

FinalInspection

100% inspection before shipment

FinalInspection
PackagingVerification

PackagingVerification

Labelbarcode and packagingcheck

PackagingVerification

LABORATORY & TESTING CAPABILITY

Environmental & Reliability Testing

• High / Low Temperature Testing
• Humidity Resistance Testing
• Aging & Durability Evaluation
• Material Stability Verification

Material & Chemical Testing

• Raw Material Inspection
• Chemical Compatibility Testing
• Adhesion & Surface Evaluation
• Basic Chemical Analysis

Quality Control Equipment

• Laboratory Fume Hood
• Constant Temperature Chamber
• Precision Electronic Scales
• Laboratory Workstations
• Sample Storage & Inspection Area

Production Quality Assurance

• Incoming Material Inspection (IQC)
• In-Process Quality Control (IPQC)
• Final Random Inspection (FRI)
• Batch Traceability Management

15+

15+

Years

Industry Experience

200+

200+

SKILLED WORKERS

20,000+

20,000+

m2

Factory Area

5,000,000+

5,000,000+

KITS

Annual Production Capacity

50+

50+

COUNTRIES

Global Market Coverage