ISO13485：2016FDA-QSR820临床评价程序-中英文对照.pdfVIP

质量管理体系QualityManagementSystem文件编号DocNo.:QSP0722

程序名称：临床评价版本DocRev.:ACRxxxx

ProcedureName:ClinicalEvaluation页次PageNo.:1/9

1.0目的PURPOSE

EstablishproceduresforclinicalevaluationfollowingguidanceunderMEDDEV2.7/1.

2.0范围SCOPE

ForownbrandmedicaldeviceregisteredunderEuropeanCommission.

3.0参考文件REFERENCESDOCUMENT

3.1.QSP0809上市后监察PostMarketSurveillance

3.2.QSP0810不良事件的监测IncidentReportingandRecall

3.3.MEDDEV2.7/1GuidelinesonMedicalDevices–ClinicalEvaluation

3.4.MEDDEV2.12/2GuidelinesonPostMarketClinicalFollow-Up

3.5.REGULATION(EU)2017/745onMedicalDevice

3.6.ISO14155Clinicalinvestigationofmedicaldevicesforhumansubjects–Goodclinicalpractice

4.0定义DEFINITION

4.1.ClinicalEvaluation(MEDDEV2.7/1)

临床评价：不间断收集、评价和分析适合于医疗器械的临床数据，评价是否足够充分的临床

证据来确认在根据制造商的使用说明书使用设备时，符合相关安全和性能相关的基本要求。_A

methodologicallysoundongoingproceduretocollect,appraiseandanalyseclinicaldatapertainingtoa

medicaldeviceandtoevaluatewhetherthereissufficientclinicalevidencetoconfirmcompliancewith

relevantessentialrequirementsforsafetyandperformancewhenusingthedeviceaccordingtothe

manufacturer’sInstructionsforUse.

4.2.Clinicaldata(MEDDEV2.7/1)

由医疗器械的临床使用生成的安全和/或性能信息

Safetyand/orperformanceinformationthatisgeneratedfromtheclinicaluseofadevice.

5.0职责RESPONSIBILITY

5.1.Marketingisresponsibleforthecollectionoftheclinicaldatageneratedfromtheclinicaluseofthe

concerneddevi