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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
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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臨床試驗工作流程圖，簡要說明了臨床試驗的各個階段，各階段主要工作流程及要求。 Time:2018/7/9 16:15:38 View:2561
醫療器械臨床服務流程根據《醫療器械監督管理條例》（國務院令第650號）的規定，第Ⅰ類醫療器械實行產品備案管理，不需要進行臨床試驗，但需要提交臨床評價資料；第Ⅱ、Ⅲ類醫療器械注冊時，應當進行臨床試驗（免于進行臨床試驗的第Ⅱ類醫療器械目錄；免于進行臨床試驗的第Ⅲ類醫療器械目錄的醫療器械除外）；免于進行臨床試驗的醫療器械，在進行注冊申報時，仍需提供臨床評價資料。 Time:2018/6/29 11:32:16 View:2292

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