We are pleased to announce that AIRSKY TECHNOLOGY CO., LTD. has been officially certified for:
- ISO 13485:2016 – Quality Management System for Medical Devices
This certification has been awarded by Pacific Certifications, a certification body accredited by ABIS, following a thorough audit of the company’s quality management system, operational controls, and regulatory compliance specific to the medical device industry.
About ISO 13485:2016 Certification:
ISO 13485:2016 is an internationally recognized standard designed for organizations involved in the design, production, installation, and servicing of medical devices and related services. Achieving this certification demonstrates that AIRSKY TECHNOLOGY CO., LTD.:
- Maintains a consistent, robust quality management system
- Meets applicable regulatory requirements for medical devices
- Ensures safety, effectiveness, and quality throughout the product lifecycle
- Is committed to continuous improvement and risk management practices
We extend our congratulations to the entire team at AIRSKY TECHNOLOGY CO., LTD. for this achievement and their dedication to advancing quality and regulatory excellence in the medical device industry.
