江苏科标医学技术集团有限公司是专注服务大健康领域的第三方专业检测机构。场地面积达23000㎡,总部位于江苏省常州市两湖创新区,目前在苏州、深圳均有试验场所。我们的服务以动物、微生物、物理、化学为基础,植入、介入产品为特色,可为医疗器械或药品生产企业新产品快速上市提供专业、快捷、可靠的验证方案及测试服务。目前,已累计服务超6000家企业,出具的检测报告符合医疗器械多国多地区注册法规要求。
Jiangsu Kerbio Medical Technology Group Co., Ltd.is a professional testing organization that specializes in serving the manufacturers of medical devices, instrument materials, cosmetics, disinfection products and packaging materials. It can provide enterprises with product safety and efficacy evaluation, as well as monitoring, verification and testing of various purification facilities. Our services are based on animals, microorganisms, physics and chemistry, and focus on implantation and intervention products.
服务项目涵盖:
1、生物学评价与试验
2、临床前大动物试验
3、化学分析
4、微生物检测
5、医疗器械包装验证
6、洁净室检测及设施验证
7、医疗器械物理性能检测
8、医美器械专项检测
9、眼科综合平台
10、生物制品检定
Services include:
1. Biocompatibility
2. Pre-clinical large animal experiment
3. Chemical analysis
4. Microbial detection
5. Packaging verification
6. Clean room detection
7. Medical device performance testing
8. Specialized testing for medical aesthetic devices
9. Ophthalmology research service
10. Biologics testing