Elim Medical Technology (Suzhou)Co., Ltd. Achieves ISO 13485:2016 Certification

Strengthening Commitment to Global Medical Device Quality Standards

Elim Medical Technology Co., Ltd., a leading innovator in medical device solutions, is proud to announce the successful attainment of ISO 13485:2016 Certification for its Quality Management System (QMS). This prestigious accreditation, awarded by CADIA Standard Certification (Beijing) Co., Ltd. (Certificate No. G25Q2SZ1190R0S), validates the company’s adherence to rigorous international standards for medical device design, production, and regulatory compliance.

Scope of Certification

The certification specifically covers the production of advanced medical curtains (for export), underscoring Elim Medical’s expertise in manufacturing high-quality, compliant medical products for global markets.

Commitment to Excellence

ISO 13485:2016, titled Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes, is the globally recognized benchmark for ensuring medical device safety, efficacy, and regulatory compliance. By achieving this certification, Elim Medical Technology demonstrates its unwavering dedication to:

   Implementing robust quality control processes

   Meeting stringent regulatory requirements across target markets

   Prioritizing patient safety and product reliability

Leadership Statement

“This certification is a testament to our team’s hard work and our promise to deliver excellence,” said Mr Yu, CEO of Elim Medical Technology. “We are committed to maintaining the highest standards in medical device manufacturing, and this milestone reinforces our ability to serve international partners with confidence.”

Future Outlook

With ISO 13485:2016 certification, Elim Medical Technology is poised to expand its global footprint while upholding its mission to advance healthcare through innovative, reliable solutions. The company remains focused on continuous improvement, regulatory compliance, and customer satisfaction.

About Elim Medical Technology Co., Ltd.

Elim Medical Technology Co., Ltd. is a forward-thinking enterprise specializing in the research, development, and production of cutting-edge medical devices. With a focus on innovation and quality, the company serves healthcare providers worldwide, delivering solutions that enhance patient care and operational efficiency.

Elim Medical Technology Co., Ltd. – Pioneering Quality in Healthcare

Key Details Included:

   Certification body (CADIA) and certificate number

   Effective date (July 31, 2025)

   Certified product scope (medical curtains for export)

   Strategic emphasis on global compliance and patient safety

This structure balances professionalism with readability, positioning the certification as a milestone in the company’s growth while reinforcing credibility for international partners.