Recently, AmcareMed successfully passed the audit of BSI (British Standards Institution), an international authoritative certification body, and successfully obtained the ISO13485:2016 (hereinafter referred to as “ISO13485”) international standard certification.

ISO13485 is the “Quality Management System for Medical Devices – Requirements for regulatory purposes”, which is used to promote the quality of medical devices to achieve safety and effectiveness.

The ISO13485 certification means that AmcareMed medical gas products have met the requirements of national and industry standards, marking AmcareMed standardisation and systematic management in the medical device industry, and reflecting AmcareMed’s high regard for quality management.

In the future, amcaremed will continue to increase its investment in quality management, make product safety one of the company’s highest priorities, continuously improve itself through technological and management innovation, implement quality control measures from top to bottom, deepen the construction of quality management systems, improve the overall production capacity of medical gas products and solutions, and explore and create safe, compliant and innovative medical gas products together with customers and partners.