文档介绍：DocumentTitleDocumentNumberDate DesignReviewChecklistProjectNumber:ProjectName:--------------ReviewDate:-----------CheckAppropriateDesignReview:DDesignReviewIPlanningPhaseDDesignReviewIIRequirementsPhaseDDesignReviewIIIProductDesignPhaseDDesignReviewIVImplementationPhaseDDesignReviewVVerificationPhaseDDesignReviewVIValidationPhaseDDesignReviewVIIDesignTransferPhaseDOther(explain):DesignReviewDeliverables:ordancewithappropriateprojectphase,per----SOP,:AttendanceList:□Attached□NotRequired/NotApplicable□Attached□NotApplicableDesignReviewApproval-------------EngineeringDateMarketing------RegulatoryAffairsDateQualityAssuranceManufacturingDateCTOClinicalAffairsDateDateDateDateITitle:DesignControlNum:Rev:BType:IPage1of17SOPDocumentOwner: EngineeringApproversRequired: QualityAssurance RegulatoryAffairsManufacturingEngineeringRevisionHistoryI I i.'ApprovalIIssueIEffective·Rev DCNI' NatureofChange I i Date: IDate:. Date--------------------------~~~~~~~~~~~~IA 0004IInitialDeNRelease I I 1 B I ,,.,thoseassociatedwiththeplanning,design,developmentandreleaseofnewproducts,,,includingbasicresearch,conceptdevelopment,-2003MedicalDevices-QualityManagementSystems-RequirementsforIregulatorypurposes,includingtheStandardsCouncilofCanada(SCC)IandCanadianMedicalDevicesConformityAssessmentSystem(CMDCAS).ISOPMedicalDevicesRegulationsforCanada(SOR/98-282)IIiISO14971-2000MedicalDevices-ApplicationofRiskManagementtoMed