美国医疗器械开发流程(FDA).doc

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1、.DocumentTitleDocumentNumberDateDesignReviewChecklistProjectNumber:ProjectName:--------------ReviewDate:-----------CheckAppropriateDesignReview:DDesignReviewIPlanningPhaseDDesignReviewIIRequirementsPhaseDDesignReviewIIIProductDesignPhaseDDesignReviewIVImplementationPhaseDDesignReviewVVerifi

2、cationPhaseDDesignReviewVIValidationPhaseDDesignReviewVIIDesignTransferPhaseDOther(explain):DesignReviewDeliverables:Listdeliverablesinaccordancewithappropriateprojectphase,per----SOP,DesignControl.Attachadditionalsheetsifnecessary.ActionItemList:AttendanceList:□Attached□NotRequired/NotAppl

3、icable□Attached□NotApplicable专业资料.DesignReviewApproval-----------_._--EngineeringDateMarketing------RegulatoryAffairsDateQualityAssuranceManufacturingDateCTOClinicalAffairsDateDateDateDate专业资料.ITitle:DesignControl1Num:Rev:BType:IPage1of17SOPDocumentOwner:EngineeringApproversRequired:Quality

4、AssuranceRegulatoryAffairsManufacturingEngineeringRevisionHistoryIIi.'ApprovalIIssueIEffective·RevDCNI'NatureofChangeIiDate:IDate:.Date--------------------------~~~~~~~~~~~~IA0004IInitialDeNReleaseII1BIIIII1.PURPOSETodefineresponsibilitiesanddescribethedesigncontrolprocessbywhichnewproducts

5、andrevisionstoexistingproductsareplanned,developedandreleasedintoproduction.2.SCOPEThisprocedureappliestoallproductdevelopmentactivities,i.e.,thoseassociatedwiththeplanning,design,developmentandreleaseofnewproducts,aswellaschangestomatureproducts.Whendocumentedandapprovedaspartoftheprojectp

6、lan,adevelopmentactivitymaydeviatefromthedesigncontrolprocessdescribedherein.Thisprocedureisnotintendedtoapplytoresearchactivities,includingbasicresearch,conceptdevelopment,orfeasibilitystudies.3.REFERENCEDOCUMENTSI21CFRPart820.30QualitySystemRegulationIIISO13485-2003MedicalDevices-QualityM

7、anagementSystems-RequirementsforIregulatorypurposes,includingtheStandardsCouncilofCanada(SCC)IandCanadianMedicalDevicesConformityAssessmentSystem(CMDCAS).ISOPMedicalDevicesRegulationsforCanada(SOR/98-282)IIiISO14971-2000MedicalDevices-ApplicationofRiskMa