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浙江省医疗器械检验研究院 | Zhejiang Institute of Medical device testing


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浙江省医疗器械检验院(MDST),成立于1977年,浙江省食品药品监督管理局(ZJFDA)的直属事业单位,是国家食品药品监督管理总局(CFDA)的10个国家级医疗器械检验中心之一,是一家专业从事医疗器械质量监督检验和医疗器械产品认证检测的国家级检验机构。机构规格相当于正处级,为公益一类事业单位。

   现有在职员工160人,技术人员占总人数85%以上。其中博士后1人,研究生学历32人,本科以上100人。教授级高工8人,高级工程师含副教授、副研究员18人;国家实验室认可(CNAS)主任评审员1人,技术评审员2人;国家ISO9000以及ISO13485质量体系高级审核员3 人。   

   承建"浙江省医疗器械安全性评价研究省级重点实验室"。为国内首家医疗器械安全评价重点实验室,主要研究方向为光辐射安全研究、医用电气设备安全性和使用安全评估、生物相容性评价研究。为省内医疗器械研究和生产者提供对外开放的安全评价研究平台。


单位网站:http://www.mdst.org.cn


Zhejiang Institute of Medical Device Testing(MDST), established in 1977, is a public institution directly under Zhejiang Food and Drug Administration (ZJFDA). It is one of the 10 national medical device inspection centers of the China Food and Drug Administration (CFDA). It is a national inspection institution specializing in medical device quality supervision and inspection as well as medical device product certification and testing. The organization specification is equivalent to the department level, and it is a kind of public welfare institution.
At present, there are 160 employees, and technical personnel account for more than 85% of the total number. Among them, there are 1 postdoctoral, 32 postgraduates and 100 undergraduates. There are 8 professor level senior engineers, 18 senior engineers including associate professors and associate researchers; 1 CNAS chief reviewer, 2 technical reviewers; 3 National ISO9000 and ISO13485 quality system senior auditors.  
Established "Zhejiang Provincial Key Laboratory of medical device safety evaluation", the first key laboratory of medical device safety evaluation in China, mainly about light radiation safety research, safety evaluation of medical electrical equipment, and biocompatibility evaluation research. It provides an open safety evaluation research platform for medical device research and manufacturers in Zhejiang province.

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