softwareneededtorundevice-specificfunctions.However,OTSSoftwareintendedforgeneral- purposecomputingmaynotbeappropriateforagivenspecificuseinamedicaldevice.The medicaldevicemanufacturerusingOTSSoftwaregenerallygivesupsoftwarelifecyclecontrol, butstillbearstheresponsibilityforthecontinuedsafeandeffectiveperformanceofthemedical ...
包括一份详细的 CAPA 计划,全面纠正公司的文件操作,以确保在整个操作过程中保留可追溯的、清晰的、完整的、原始的、准确的、同步的记录。 For further reference regarding heparin, see the guidance for industry Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality available online at ...
industriesincludingMedical,Aerospace,Defense,andCommunicationIndustries.Wesupportthe deviceindustriesbutarenotthelegalmanufactureroftheendproduct. Thismanualisusedinternallytoguidethecompany’semployeesthroughthevariousrequirements oftheISOstandardthatmustbemetandmaintainedinordertoensurecustomersatisfaction, ...
(2)Designvalidationmeansestablishingbyobjectiveevidencethatdevicespecifications conformwithuserneedsandintendeduse(s). (aa)验证Verification。通过检查和提供客观证据证明满足规定的要求。 (aa)Verificationmeansconfirmationbyexaminationandprovisionofobjectiveevidencethat 美国FDA_医疗器械体系法规QSR820中英文版--第8页 美国...
26、 appropriate, in the medical device regulations, safety, labeling, human factors, verification, validation, design review techniques, etc.合适时,大多数技术类员工都需要不同程度的培训,培训的方面包括医疗器械规章、安全、标识、人为因素、确认、验证、设计评审技术等。 design and development planning设 计...
All(b)(4)sample results were stored in an uncontrolled folder that could be manipulated by any user. 所有XX样品结果均保存在一个任何用户均可修改的不受控文件夹中 The(b)(4)and(b)(4)equipment were used by numerous people at t...
LPM:Laboratory Procedures Manual:实验室流程手册 M&IE:Meals and Incidental Expenses:食杂费 MDUFMA:Medical Device user Fee & Modernization Act:医疗设备使用收费与现代化法案 MDQS:Medical Device Quality System:医疗设备质量管理体系 MOA:Ministry of Agriculture:农业部 MOU:Memoranda of Understanding:谅解备忘录...
FDA puts medical device manual on Internet 来自 EBSCO 喜欢 0 阅读量: 11 摘要: Announces the availability over the internet of the medical device manual of Center for Devices and Radiological Health of the Food and Drug Administration. 年份: 1997 ...
( UserManual-DraftT CIR:CustomerInputRequirements rainingMaterial: CP:CompliancePlan ImplementationPhase ~ Draft DDP:Design DevelopmentPlanDH InstallationProced F:DesignHistoryFile ures:Draft DMR:DeviceMasterRecord DR_DesignReview FMEA:FailureModes EffectsAnalysisHW: VerificationPhase Hardware(Electrical Mechanical...
15、 in user manual.Page: 4 of 54)Place each inoculated device in a separated steam sterilization pouch along with one (1) BI spore strip and one CI . See Figure1.5)Seal and number the pouches.6)Using a pouch divider for positioning, place the pouched devices on the bottom shelf above...