欢迎来到第壹文秘! | 帮助中心 分享价值,成长自我!
第壹文秘
全部分类
  • 幼儿/小学教育>
  • 中学教育>
  • 高等教育>
  • 研究生考试>
  • 外语学习>
  • 资格/认证考试>
  • 论文>
  • IT计算机>
  • 法律/法学>
  • 建筑/环境>
  • 通信/电子>
  • 医学/心理学>
  • ImageVerifierCode 换一换
    首页 第壹文秘 > 资源分类 > DOCX文档下载
    分享到微信 分享到微博 分享到QQ空间

    PMS报告模板(英文).docx

    • 资源ID:558838       资源大小:25.55KB        全文页数:6页
    • 资源格式: DOCX        下载积分:5金币
    快捷下载 游客一键下载
    账号登录下载
    三方登录下载: 微信开放平台登录 QQ登录
    下载资源需要5金币
    邮箱/手机:
    温馨提示:
    快捷下载时,如果您不填写信息,系统将为您自动创建临时账号,适用于临时下载。
    如果您填写信息,用户名和密码都是您填写的【邮箱或者手机号】(系统自动生成),方便查询和重复下载。
    如填写123,账号就是123,密码也是123。
    支付方式: 支付宝    微信支付   
    验证码:   换一换

    加入VIP,免费下载
     
    账号:
    密码:
    验证码:   换一换
      忘记密码?
        
    友情提示
    2、PDF文件下载后,可能会被浏览器默认打开,此种情况可以点击浏览器菜单,保存网页到桌面,就可以正常下载了。
    3、本站不支持迅雷下载,请使用电脑自带的IE浏览器,或者360浏览器、谷歌浏览器下载即可。
    4、本站资源下载后的文档和图纸-无水印,预览文档经过压缩,下载后原文更清晰。
    5、试题试卷类文档,如果标题没有明确说明有答案则都视为没有答案,请知晓。

    PMS报告模板(英文).docx

    Post-MarketSurveillance(PMS)/RiskManagementPlanTemplateTMP-031(ParentProcedureSYS-019)Version:aD2Effective:Author:M.WalkerPage:1of6Purpose:Todefinetheprocessandfrequencyofactivitiesforgatheringproductionandpostproductiondataasaninputintotheclinicalevaluationprocess(SYS-041)andriskmanagementprocess(SYS-010).Scope:Thescopeofthispost-marketsurveillanceplanislimitedtotheProductFamilyNameduringtheperiodofearliestdatetolatestdate.Thepost-marketsurveillancesystemreferredtoinArticle83ofRegulation(EU)2017/745shallbebasedonapost-marketsurveillanceplan,therequirementsforwhicharesetoutinSection1.1ofAnnexIII.Fordevicesotherthancustom-madedevices,thepost-marketsurveillanceplanshallbepartofthetechnicaldocumentationspecifiedinAnnexII.Thisplanalsoaddressestheproductionandpost-productionactivitiesrequiredaspartoftheriskmanagementprocessasdefinedinISO14971:2019,Clause10.Note:IfdifferentPMSandRiskManagementinputscoverdifferentperiodsoftime,thenthisshouldbeclarifiedinthePMSreports(TMP-032)andRiskManagementreports(TMP-027).Oftenatableisidealtocommunicatethisinformation.Thesetworeporttemplatesmayalsobecombinedintoasinglereport.Responsibilities&Authorities:ThetableinthePMSinputssectiondefinesthepersonnelthatareresponsibleforgatheringeachtypeofPMSdataforProductFamilyName.Eachpersonisresponsibleforgatheringthedata,summarizingthatdata,writingabriefdiscussionofthedataanalysisanddocumentingaconclusionthatstateswhetherthedatawarrantsupdatingthePMSreportatthistimeortocontinuegatheringdatauntilthenextcycleiscompleted.Evenifthereisnonewclinicaldatagatheredduringtheperiod,theclinicalevaluationreportstillrequiresupdatingtheliteraturesearch,gatheringofcomplaintdata,andIftheliteraturesearchconcludesthatthereisnonewclinicaldataavailable,documentboththemethodologyandtheresultsofthesearch.Iftherearenonewrisksidentifiedandthedatasuggeststhatnochangestothecurrentriskanalysisareneeded,thentheriskanalysismaynotneedtobeupdatedeither,butdocumenttheactivitiesthatledtothatconclusion.Therecommendedfrequencyforthenextsummaryofdatashouldbeindicatedintheconclusionaswell.TechnicalDocumentationonPost-MarketSurveillanceThetechnicaldocumentationonpost-marketsurveillancetobedrawnupbytheCompanyNameinaccordancewithReg.(EU)2017/745,Articles83to86shallbepresentedinaclear,organized,readilysearchableandunambiguousmanner.ThePost-MarketSurveillancePlanshallbepartoftheTechnicalDocumentation.Post-MarketSurveillance(PMS)/RiskManagementPlanTemplateTMP-031(ParentProcedureSYS-019)Version:aD2Effective:Author:M.WalkerPage:2of6AsrequiredwithinAnnexIII,Section1.1a)ofReg.(EU)2017/745thePost-MarketSurveillancePlanshalladdressthecollectionandutilizationofavailableinformation,inparticular: informationconcerningseriousincidents,includinginformationfromPeriodicSafetyUpdateReports(PSUR)s(TMP-033)jandfieldsafetycorrectiveactions; recordsreferringtonon-seriousincidentsanddataonanyundesirablesideeffects; informationfromtrendreporting; relevantspecialistortechnicalliterature,databasesand/orregisters; information,includingfeedbacksandcomplaints,providedbyusers,distributorsandimporters;and publiclyavailableinformationaboutsimilarmedicaldevices.AsrequiredwithinAnnexIII,Section1.1b)ofReg.(EU)2017/745thePost-MarketSurveillancePlanshallcoveratleast: aproactiveandsystematicprocesstocollectanyinformationreferredtoaboveinpoint(a).Theprocessshallallowacorrectcharacterizationoftheperformanceofthedevicesandshallalsoallowacomparisontobemadebetweenthedeviceandsimilarproductsavailableonthemarket; effectiveandappropriatemethodsandprocessestoassessthecollecteddata; suitableindicatorsandthresholdvaluesthatshallbeusedinthecontinuousreassessmentofthebenefit-riskanalysisandoftheriskmanagementasreferredtoinReg.(EU)2017/745,Section3ofAnnexI; effectiveandappropriatemethodsandtoolstoinvestigatecomplaintsandanalyzemarket-relatedexperiencecollectedinthefield; methodsandprotocolstomanagetheeventssubjecttothetrendreportasprovidedforinReg.(EU)2017/745,Article88,includingthemethodsandprotocolstobeusedtoestablishanystatisticallysignificantincreaseinthefrequencyorseverityofincidentsaswellastheobservationperiod; methodsandprotocolstocommunicateeffectivelywithcompetentauthorities,notifiedbodies,economicoperatorsandusers; ReferencetoprocedurestofulfiltheCompanyName,sobligationslaiddowninReg.(EU)2017/745,Articles83,84and86; systematicprocedurestoidentifyandinitiateappropriatemeasuresincludingcorrectiveactions; effectivetoolstotraceandidentifydevicesforwhichcorrectiveactionsmightbenecessary;and aPost-MarketClinicalFollow-up(PMCF)PlanasreferredtoinReg.(EU)2017/745,PartBofAnnexXIV,orajustificationastowhyaPMCFisnotapplicable(seePMCFPlanChecklist-TMP-008)Post-MarketSurveillance(PMS)/RiskManagementPlanTemplateTMP-031(ParentProcedureSYS-019)Version:aD2Effective:Author:M.WalkerPage:3of6AsrequiredwithinAnnexIII,Section1.2ofReg.(EU)2017/745thePSUR(TMP-033)referredtoinArticle86andthepost-marketsurveillancereportreferre

    注意事项

    本文(PMS报告模板(英文).docx)为本站会员(p**)主动上传,第壹文秘仅提供信息存储空间,仅对用户上传内容的表现方式做保护处理,对上载内容本身不做任何修改或编辑。 若此文所含内容侵犯了您的版权或隐私,请立即通知第壹文秘(点击联系客服),我们立即给予删除!

    温馨提示:如果因为网速或其他原因下载失败请重新下载,重复下载不扣分。




    关于我们 - 网站声明 - 网站地图 - 资源地图 - 友情链接 - 网站客服 - 联系我们

    copyright@ 2008-2023 1wenmi网站版权所有

    经营许可证编号:宁ICP备2022001189号-1

    本站为文档C2C交易模式,即用户上传的文档直接被用户下载,本站只是中间服务平台,本站所有文档下载所得的收益归上传人(含作者)所有。第壹文秘仅提供信息存储空间,仅对用户上传内容的表现方式做保护处理,对上载内容本身不做任何修改或编辑。若文档所含内容侵犯了您的版权或隐私,请立即通知第壹文秘网,我们立即给予删除!

    收起
    展开