上海岙瑟检测技术有限公司,0rthotek Lab(ISO17025:2017认证) , 致力于外科植入介入产品体外性能检测和医工合作研究的第三方检测平台,由上海大学生物力学实验室孵化而成,具备CNAS\CMA\IAS等认证资质。
Orthotek provides professional testing services for orthopedic, dental implants, cardiovascular intervention and sports medicines, surgical tools, and etc, especially the biomechanical tests, wear tests, FEA simulation, and failure analysis.
检测服务涵盖骨科植入物、心血管介入、齿科种植体、运动医学等各类外科植入介入物产品及手术工具的性能检测、计算机模拟仿真和失效分析。
已支持200多家植入介入企业完成产品性能分析与检验检测,并获得NMPA、美国FDA、欧洲CE、南美、中东等国内外医疗器械注册证。拥有200多台套专业检测设备,包括关节磨损实验机、疲劳实验机、医用接骨螺钉扭转测试仪等自主知识产权设备,并具备检测设备定制化研发能力。与40多家医院近百位骨科、口腔、心内外、神外医学专家合作,支持20多款创新医疗器械产品研究、分析与检测。
Orthotek’s testing service has supported over 200 companies successfully registered their medical devices in NMPA, FDA, CE, An Visa, and etc.
Orthotek are running over 200 sets of testing frames, including joint wear simulators, fatigue test frames, medical bone screw torsion testers with our own IP rights. Orthotek also has professional capabilities to develop customized testing apparatus. Orthotek has solid collaboration with over 100 orthopedic, dental, cardiology, and neurology medical specialists from over 40 cooperated medical centers. Among these, Orthotek has supported R&D, verification and validation of over 20 innovative medical devices.