MDR技术文档目录.doc

TECHINCALFILE

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Tableofcontents

Section

Titlefordocumentation

TechnicalFile

00Cover

01Contents

02RevisionHistory

Chapter1

1.1BriefDescriptionoftheProduct

1.2RegulatoryInformation

1.3Technicalrequirementsofbloodcollectionneedle

1.4Productdrawing

Chapter2

2.1Instructionsforuse英文

2.1InstructionForUse立陶宛语

2.2SampleofLabelandLanguageInformation

2.2.1Labelandpackagingdrawings

2.3EUDeclarationofConformity

2.4ElectronicManualofDisposableBloodCollectionNeedles

Chapter3

3.1Designanddevelopmentinformation

3.2ProductionProcessFlowDiagram

3.3BOMandsuppliers

3.3Kindleybloodcollectionneedlerawmaterial

3.3.1Materialreportandsupplierqualification

3.4PackageInformation

3.5ManufacturingconditionsandQualityControl

3.5.1SOPandInspectionprocedure

3.6IntroductionofManufacturer

3.7EUAuthorizedRepresentativeAgreement

Chapter4

4.1GeneralSafetyandPerformanceRequirements(GSPRs_MDR)

4.2Harmonisedstandardslists;

Chapter5

5.1RiskManagementPlan

5.2Riskmanagementreport

Chapter6

6.1Preclinicalandclinicaldata

6.2Biocompatibilityassessmentandtestreport

6.3Performancetestingreport

6.4Usabilityevaluationreport

6.5Sterilizationvalidationreport

6.6PackageQualificationandShelfLifevalidationreport

6.7Cleanroomtestreport

6.8Clinicalevaluation

6.9PMSplan

6.10PSUR

6.11VigilanceSystem

6.12PMCF

6.13Transportationengineeringevaluation

Revisionhistory

RevisionChapter

RevisionContent

RevisionReason

RevisionDate

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