In July 14-15, Hefei CAS Ion Medical Technical Devices Co., Ltd. Successfully Passes ISO9001 and ISO13485 Certification Examination by Beijing Guoyi Medical Device Huaguang Certification Co., Ltd.

This exam covered the entire process of design, development, and production of the superconducting proton therapy system (including cyclotron, rotating gantry, beam line, energy selection system, control system, and image guidance system) currently under research and development, as well as the related functional departments' procedural records. The exam team conducted a comprehensive and detailed examination of HFCIM's quality management system for compliance, appropriateness, effectiveness, and scientific soundness through on-site inspections of research and development and production, reviewing relevant records and documents, and interviewing relevant personnel.

The exam team concluded that HFCIM has a clear organizational structure, well-defined responsibilities and authorities, scientifically and logically sound technical documents, and a system that strictly adheres to quality procedure documents, demonstrating overall system integrity. The certification team announced the result: Hefei CAS Ion Medical and Technical Devices Co., Ltd.'s quality management system is effectively implemented, achieving established quality objectives, and complies with the requirements of ISO9001 and ISO13485. Additionally, professional suggestions were provided for the continuous improvement of the company's quality management system.

The leadership expressed gratitude for the thorough and meticulous exam conducted by the expert team and the valuable suggestions provided. They hope that the certification center will continue to support to HFCIM's quality management work in the future. The leadership made the following statements: First, they will continue to strictly adhere to the requirements of the ISO9001 and ISO13485 standards, continually improving HFCIM's quality system. Second, they will optimize identified issues in accordance with the requirements of the exam team, carefully analyze the reasons, formulate rectification plans and measures, and complete the corrections within the specified timeframe. Third, through this quality system verification, they have gained a clearer understanding of the importance of quality standards in the research and development design process.