Company NewsAugust 20, 2012·1 min read

Xinke Medical Obtains ISO 13485 Certification for Medical Device Quality Management

Xinke Medical has successfully obtained ISO 13485 certification for its medical device quality management system, demonstrating that the company's quality management in the medical device field meets international standards.

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Xinke Medical

Published August 20, 2012

Xinke Medical Obtains ISO 13485 Certification for Medical Device Quality Management

Zhejiang Xinke Medical Technology Co., Ltd. has recently successfully passed ISO 13485 certification for its medical device quality management system, another important milestone for the company following its ISO 9001 certification.

Significance of the Certification

ISO 13485 is the internationally recognized standard for medical device quality management systems. Passing this certification means:

  • the entire product design, development and production process complies with international standards
  • the quality management system meets the requirements of the medical device industry
  • a solid foundation is laid for entering international markets

    • Rigorous Requirements

    To pass the ISO 13485 certification, Xinke Medical carried out a comprehensive upgrade of its quality management system:

  • complete design control procedures were established
  • production process control was strengthened
  • the traceability system was improved
  • risk management was reinforced

    • Assurance for Customers

    With the certification in place, Xinke Medical will provide customers with even more reliable product quality assurance, ensuring that every batch of reagent products meets international quality standards.

    Xinke Medical Obtains ISO 13485 Certification for Medical Device Quality Management | Xinke Medical