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1、FDA醫(yī)療器械質(zhì)量體系手冊本文翻譯自：FDA醫(yī)療器械質(zhì)量體系手冊:小實體（醫(yī)療器械企業(yè)）認證指南第一版FDA網(wǎng)站上可查到原文MedicalDeviceQualitySystemsManual醫(yī)療器械質(zhì)量體系手冊ASmallEntityComplianceGuideFirstEdition(SupersedestheMedicalDeviceGoodManufacturingPractices[GMP]Manual)小實體企業(yè)認證指南第一版（用于取代原醫(yī)療器械GMP手冊）Chapters章節(jié)Coverpage,Preface,Foreword首頁，前言Tab
2、leofContents目錄1.TheQualitySystemRegulation1.質(zhì)量體系法規(guī)2.QualitySystems2.質(zhì)量體系3.DesignControls3.設計控制4.ProcessValidation4.流程驗證5.PersonnelandTraining5.人員和培訓6.BuildingsandEnvironment6.建筑和環(huán)境7.EquipmentandCalibration7.設備和校準8.DeviceMasterRecord8.器械主記錄9.DocumentandChangeControl9.文檔和變更控制10.Purc
3、hasingandAcceptanceActivities10.采購和接收活動11.Labeling11.標簽12.ProductEvaluation12.產(chǎn)品評價13.Packaging13.包裝14.Storage,DistributionandInstallation14.存儲，分發(fā)和安裝15.Complaints15.投訴16.Servicing16.售后服務17.QualitySystemsAudits17.質(zhì)量體系審計18.FactoryInspections18.工廠檢查19.Appendices19.附件Coverpage,Preface,
4、ForewordHHSPublicationFDA97-4179首頁，前言MEDICALDEVICEQUALITYSYSTEMSMANUAL:ASMALLENTITYCOMPLIANCEGUIDEFirstEdition(SupersedestheMedicalDeviceGoodManufacturingPracticesManual)AndrewLowery,JudyStrojny,andJosephPuleoDivisionofSmallManufacturersAssistanceOfficeofHealthandIndustryProgramsC
5、ENTERFORDEVICESANDRADIOLOGICALHEALTHCDRHDecember1996(ThispublicationsupersedesFDA91-4179)U.S.DEPARTMENTOFHEALTHANDHUMANSERVICESPublicHealthServiceFoodandDrugAdministrationCenterforDevicesandRadiologicalHealthRockville,Maryland20850FOREWORD前言TheCenterforDevicesandRadiologicalHealth
6、(CDRH)oftheFoodandDrugAdministration(FDA),developsandimplementsnationalprogramstoprotectthepublichealthinthefieldsofmedicaldevicesandradiologicalhealth.Theseprogramsareintendedtoassurethesafety,effectiveness,andproperlabelingofmedicaldevices,tocontrolunnecessaryhumanexposuretopote
7、ntiallyhazardousionizingandnon-ionizingradiation,andtoassurethesafe,efficacioususeofsuchradiation.FDA器械及放射衛(wèi)生中心（CDRH）開發(fā)并實施醫(yī)療器械及放射衛(wèi)生領域旨在保護公共健康的國家項目。這些項目是為了確保醫(yī)療器械的安全，有效和正確標志，控制人體暴露于潛在的電離或非電離放射性危害，以及確保安全有效地使用此類輻射。TheCenterpublishestheresultsofitsworkinscientificjournalsandinitsowntech
8、nicalreports.Thesereportsdissemin
