Needleless Corporation Successfully Renews BSI ISO 13485:2016 Certification — Global Recognition of Quality Management System

Needleless Corporation has been awarded the ISO 13485:2016 Quality Management System Certification by the British Standards Institution (BSI), under certificate number MD 659449, valid from July 17, 2023 to July 16, 2026.
This certification reaffirms Needleless Corporation’s full compliance with international medical device quality management standards, demonstrating its strong commitment to product safety, regulatory compliance, and continuous improvement.

Clear Certification Scope Reinforces Core Product Quality Assurance

The certification scope includes:

• Design and manufacture of sterile intravascular administration set

• Design and manufacture of sterile drug transfer device

This scope highlights Needleless Corporation’s core competence in sterile medical products, ensuring that every stage—from design and manufacturing to inspection and release—operates in accordance with international standards and maintains consistent effectiveness of the quality management system.

Sustaining Quality Excellence and Strengthening Global Market Presence

Since first obtaining BSI certification in 2017, Needleless Corporation has continuously maintained an effective ISO 13485 system, successfully passing multiple surveillance and recertification audits.
The renewed certification demonstrates the company’s maturity and stability in quality management and reinforces global trust in its medical device manufacturing capabilities.
Needleless Corporation remains dedicated to its quality strategy of being “Quality-Oriented, Regulation-Driven, and Customer-Focused,” promoting company-wide participation and risk-based management to ensure the safety and reliability of every product delivered worldwide.