FDA Establishment
Registered Company
DavisShieldLine USA is an FDA Establishment Registered Company, maintaining strict compliance with regulatory standards across all manufacturing operations.
All factories and products receive complete FDA approvals before being packaged in our brand or our customers' packaging. Our dedicated Regulatory Department continuously monitors all manufacturing partners.
State-of-the-Art Production
Our manufacturing partners maintain world-class clean room environments and cutting-edge production lines.
Raw Material Inspection
Every raw material is tested and verified before entering production.
In-Process Quality Checks
Continuous monitoring during manufacturing ensures consistency.
Final Product Testing
Rigorous testing of finished products against FDA standards.
Final Product Testing
Rigorous testing of finished products against FDA standards.
FDA Registration
Our manufacturing partners span across 9 countries, enabling us to deliver quality products with optimal efficiency and competitive pricing.
USA
Malaysia
Mexico
Canada
Taiwan
India
China
Turkey
Thailand
Regulatory & Legal Compliance
DavisShieldLine USA maintains the highest regulatory standards, ensuring all products meet or exceed federal and international compliance requirements.
FDA 21 CFR Part 820
Quality System Regulation compliance for medical devices
GMP Standards
Good Manufacturing Practices across all facilities
ISO 13485
Quality management systems for medical devices
CE Marking
European conformity for international distribution