Medical device registration company, medical device third party registration service, medical device business license processing center, Hangzhou certification standard guest Enterprise Management Co., Ltd. official website

Registration Service of Medical Devices: CRC services Medical Device Business License Medical Device Registration Contract Research Organization ISO 13485 Quality System Certification GMP CE Certification Service FDA Registration (Filing) Software Integrity Verification Service Production process validation service ISO 15378 Medical Package System Certification ISO 13485 Internal Auditors Training Regulatory Services For Medical Devices
Information security service of medical: ISO 27001 Information Security Certification ISO 20000 Information Service Certification Information system grade protection filing Business Continuity Management Services Internal Auditor Training
Medical Software Development: Software of Good Supply Practice(GSP) Production System Development Customized software development

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IVD clinical trial workflow chart IVD临床试验工作流程图，简要说明了临床试验的各个阶段，各阶段主要工作流程及要求。 Time:2018-7-9 16:15:38 View:2080
医疗器械临床服务流程根据《医疗器械监督管理条例》（国务院令第650号）的规定，第Ⅰ类医疗器械实行产品备案管理，不需要进行临床试验，但需要提交临床评价资料；第Ⅱ、Ⅲ类医疗器械注册时，应当进行临床试验（免于进行临床试验的第Ⅱ类医疗器械目录；免于进行临床试验的第Ⅲ类医疗器械目录的医疗器械除外）；免于进行临床试验的医疗器械，在进行注册申报时，仍需提供临床评价资料。 Time:2018-6-29 11:32:16 View:1865