ABOUT US

The Zhongguancun Shuimu Medical Technology Service Group was established in 2017 and is headquartered in the Beijing Yizhuang Economic and Technological Development Zone. It is committed to accelerating the process of registration and listing of innovative medical device products, and solving the "last mile" problem of industrialization for innovative medical device companies. The Group is the chairman unit of the Clinical Trial Branch of the China Association for Medical Devices Industry, the executive vice chairman unit of the Application Evaluation Branch of the China Medical Equipment Association, and the chairman unit of the Medical Device Committee of the Beijing Pharmaceutical Association.

Company Introduction
Development History
Company Honors
Subsidiary
Team Introduction
Corporate News
Shumuk University
Beijing Zhongguancun Shuimu Medical Technology Co., Ltd.
  • We provide a full-process professional service and one-stop solutions for clinical research to global pharmaceutical and medical device innovation companies.

Beijing Zhongguancun Shuimu Medical Technology Co., Ltd.

Inspection and Testing Service Platform 最全面的检测范围 最完善的检测体系
Beijing Zhongguancun Shuimu Medical Technology Co., Ltd. has a professional R&D testing laboratory with an area of more than 3,500 square meters. It has obtained the dual certification of China Metrology Certification (national level CMA) and China National Accreditation Service for Conformity Assessment (CNAS). The authorized scope basically covers more than 95% of active medical devices and in vitro diagnostic testing projects.
  • Building 1, No. 19 Yongchang South Road, Beijing Economic and Technological Development Zone

    East China | South China | Northeast | Northwest: 18610900675/18610907598

    North China | Central China | Southwest | Hong Kong, Macao, : 17801120658/18610900670

Beijing Zhongguancun Shuimu Medical Technology Co., Ltd. 国内首家自主建立的第三方专业医疗器械检验检测机构

Beijing Zhongguancun Shuimu Medical Technology Co., Ltd., established in 2017 and located in Beijing Economic and Technological Development Zone, is the first privately established third-party professional medical device inspection and testing institution in China. The company has a professional R&D testing laboratory with an area of over 3,500 square meters. It has obtained dual certifications from China Metrology Certification (national level CMA) and China National Accreditation Service for Conformity Assessment (CNAS), with the authorized scope basically covering more than 95% of active medical devices and in vitro diagnostic testing projects. At the same time, the company's technical team, through long-term research and accumulation of medical device regulations, standards, and testing methods, incorporates regulatory and standard requirements into the full-process service provided to the client from design and development to production registration. In addition to testing and inspection, it can also assist the client in product engineering R&D rectification, build a quality system, and help clients make compliant products in the shortest time and quickly obtain certification.
The company has obtained dual certification from China Metrology Certification (national level CMA) and China National Accreditation Service for Conformity Assessment (CNAS). As of now, it has passed the accreditation of 1508 inspection and testing standard qualifications (CMA: 772; CNAS: 736), basically covering more than 95% of active medical devices and in vitro diagnostic testing projects.

Honors/Certificates

The company's professional team has strong scientific research capabilities, and has obtained 8 invention patent authorizations, 13 invention patents under substantive examination; 9 utility model patents; 38 software copyrights; participated in the formulation of 1 national standard; 4 industry standards. Participated in several research topics such as the Ministry of Industry and Information Technology's "2020 Industrial Technology Basic Public Service Platform—Construction Project of Innovation Achievement Industrialization Public Service Platform for Key Areas of Manufacturing Industry".
  • 检验检测机构资质认定证书

  • 中国合格评定国家认可委员会实验室认可证书

  • ISTA证书

  • 检验检测机构资质认定证书

The company has a professional testing laboratory and a mature R&D team. The laboratory covers an area of 3,500 square meters, including several professional laboratories for medical device electromagnetic compatibility, electrical safety, reliability, packaging testing, IVD testing, and software testing.
  • Electrical Safety Laboratory

  • Electromagnetic Compatibility Laboratory

  • Respiratory Anesthesia Laboratory

  • Semi-anechoic Laboratory

  • Reliability Laboratory

  • Mechanical Laboratory

  • Software Testing Laboratory

  • IVD Mass Spectrometry Laboratory