- 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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一、系統(tǒng)規(guī)劃階段:整理國際法律法規(guī)和客戶的要求 ;
二、系統(tǒng)建立階段:建立有害物質(zhì)管控操作程序和企業(yè)內(nèi)部流程 ;
三、系統(tǒng)開發(fā)和執(zhí)行階段:培訓(xùn)教育、管控措施實際運作和記錄、內(nèi)部審核和管理評審 ;
四、體系認(rèn)證和持續(xù)改善:由認(rèn)證機構(gòu)審核員進(jìn)行第三方的外部審核,頒發(fā)IECQ HSPM證書
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