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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
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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ISO15378醫(yī)療包材體系認證 ISO 15378標準規(guī)定了醫(yī)藥產品初級包裝材料（以下簡稱“藥包材”）生產行業(yè)應用質量管理體系ISO 9001:2015的特殊要求。它參照良好生產管理規(guī)范（GMP）要求，可用于展示組織具備能力提供能持續(xù)滿足顧客和法規(guī)要求的藥包材，并符合國際最佳慣例。ISO15378 是主要的醫(yī)藥包裝材料標準，由制藥業(yè)的利益相關方制定，向醫(yī)藥產品包裝材料的供應商提供質量管理體系 (QMS)。 Time:2018-6-29 11:37:28 View:1924

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