美国医疗器械开发流程(FDA)

《美国医疗器械开发流程(FDA)》由会员上传分享，免费在线阅读，更多相关内容在行业资料-天天文库。

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