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ID:40165108
大小:217.51 KB
页数:19页
时间:2019-07-24
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1、DocumentTitleDocumentNumberDateDesignReviewChecklistProjectNumber:ProjectName:--------------ReviewDate:-----------CheckAppropriateDesignReview:DDesignReviewIPlanningPhaseDDesignReviewIIRequirementsPhaseDDesignReviewIIIProductDesignPhaseDDesignReviewIVImplementationPhaseDDesignReviewVVerificatio
2、nPhaseDDesignReviewVIValidationPhaseDDesignReviewVIIDesignTransferPhaseDOther(explain):DesignReviewDeliverables:Listdeliverablesinaccordancewithappropriateprojectphase,per----SOP,DesignControl.Attachadditionalsheetsifnecessary.ActionItemList:AttendanceList:□Attached□NotRequired/NotApplicable□At
3、tached□NotApplicableDesignReviewApproval-----------_._--EngineeringDateMarketing------RegulatoryAffairsDateQualityAssuranceManufacturingDateCTOClinicalAffairsDateDateDateDateITitle:DesignControl1Num:Rev:BType:IPage1of17SOPDocumentOwner:EngineeringApproversRequired:QualityAssuranceRegulatoryAffa
4、irsManufacturingEngineeringRevisionHistoryIIi.'ApprovalIIssueIEffective·RevDCNI'NatureofChangeIiDate:IDate:.Date--------------------------~~~~~~~~~~~~IA0004IInitialDeNReleaseII1BIIIII1.PURPOSETodefineresponsibilitiesanddescribethedesigncontrolprocessbywhichnewproductsandrevisionstoexistingprodu
5、ctsareplanned,developedandreleasedintoproduction.2.SCOPEThisprocedureappliestoallproductdevelopmentactivities,i.e.,thoseassociatedwiththeplanning,design,developmentandreleaseofnewproducts,aswellaschangestomatureproducts.Whendocumentedandapprovedaspartoftheprojectplan,adevelopmentactivitymaydevi
6、atefromthedesigncontrolprocessdescribedherein.Thisprocedureisnotintendedtoapplytoresearchactivities,includingbasicresearch,conceptdevelopment,orfeasibilitystudies.3.REFERENCEDOCUMENTSI21CFRPart820.30QualitySystemRegulationIIISO13485-2003MedicalDevices-QualityManagementSystems-RequirementsforIre
7、gulatorypurposes,includingtheStandardsCouncilofCanada(SCC)IandCanadianMedicalDevicesConformityAssessmentSystem(CMDCAS).ISOPMedicalDevicesRegulationsforCanada(SOR/98-282)IIiISO14971-2000MedicalDevices-ApplicationofRiskManagementtoM
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