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北京创元成业科技有限公司

2021-06-08


北京创元成业科技有限公司主要从事医疗器械研发、医疗器械制造方案设计,专业为客户提供医疗器械研发、认证、EMC检测、体系管理、临床实验、生产制造一体化服务。公司历史研发产品涉及一、二、三类及保健类有源医疗器械产品,如超声刀、弹道碎石机、聚酯消融机、排痰机、血液分离机、海扶刀、纳米刀、人工心脏等。其中我公司自主研发的纳米刀和与朱晓东院士联合开发人工心这两款产品目前均处于国内领先水平。

目前公司已通过ISO9001质量体系、ISO13485体系、军工质量体系、ROHS、CMA、CE等多体系认证。目前公司拥有软件著作专利9件、实用新型专利9件,外观专利2件等多项专利。公司具有专业的技术研发团队和技术精湛的生产管理团队30余人。


Beijing Chuangyuan Chengye Technology Co., Ltd. is mainly engaged in the research and development of medical devices and the design of medical device manufacturing scheme. It is specialized in providing customers with integrated services of medical device research and development, certification, EMC testing, system management, clinical experiment and manufacturing. The company's historical R & D products involve class I, II, III and health care active medical devices, such as ultrasound knife, ballistic lithotripter, polyester ablation machine, expectoration machine, blood separator, Haifu scalpel, nano scalpel, artificial heart, etc. In these products, the Independent R D nanoknife and the joint development of artificial heart with Academician Zhu Xiaodong are both at the leading level in China.


At present, the company has passed ISO9001 quality system, ISO13485 system, military quality system, ROHS, CMA, CE and other multi system certification. The company has 9 software patents, 9 utility model patents, 2 appearance patents and other patents. The company has a professional R & D team and skilled production management team of more than 30 people.