德信誠培訓網德信誠培訓網更多免費資料下載請進： 好好學習社區更多免費資料下載請進： 好好學習社區Iajufuf.55bop.conx好好學習天天沖上上市后臨床跟蹤控制程序(ISO13485-2016)Iajufuf.55bop.conx好好學習天天沖上Table錯誤！文檔中沒有指定樣式的文字。-1:RolesandResponsibilitiesRoleResponsibilityDesignEngineeringand/orEngineeringRepresentativeProvideconsultationtotheProductRegulatoryAffairsRepresentativeindeterminingforagivenproject/productwhetherapost-marketclinicalfollow-upstudyisrequiredProvideconsultationtotheProductRegulatoryAffairsRepresentativetodetermineifanequivalentdeviceexistsProvideconsultationtotheProductRegulatoryAffairsRepresentativeinidentifyingemergingrisksforthemedicaldeviceProvideconsultationtotheResearchManagerordesigneetodeterminethetypeofpost-marketclinicalfollow-upstudytobeimplemented,ifapplicableTable錯誤！文檔中沒有指定樣式的文字。-1:RolesandResponsibilitiesRoleResponsibilityProductRegulatoryAffairsRepresentativeDetermineforagiveproject/productwhetherapost-marketclinicalfollow-upstudyisrequiredDetermineifanequivalentdeviceexistsIdentifypotentialemergingrisksReviewriskassessmentCompletethePost-MarketClinicalFollow-UpJustificationFormregardingdecisiontoperformastudyCompletethePost-MarketClinicalFollow-UpPlanformthatdetailsthepost-marketclinicalfollow-upplanDeterminehowoftenclinicaldatamustbereviewedReviewandapprovetheclinicalevaluationperformedbytheResearchManagerordesigneeRegulatoryAffairsRepresentative?ProvideconsultationtotheResearchManagertodeterminethetypeofpost-marketclinicalfollow-upstudytobeimplemented,ifapplicableResearchManagerordesigneeProvideconsultationtotheProductRegulatoryAffairsRepresentativeindeterminingforagivenproject/productwhetherapost-marketclinicalfollow-upstudyisrequiredProvideconsultationtotheProductRegulatoryAffairsRepresentativetodetermineifanequivalentdeviceexistsProvideconsultationtotheProductRegulatoryAffairsRepresentativetoidentifypotentialemergingrisksReviewthePost-MarketClinicalFollow-UpJustificationformandPost-MarketClinicalFollow-UpPlanformtoconfirmthedecisionsregardingtheneedforapost-marketclinicalfollow-upstudyandclinicalfollow-upDeterminehowoftenclinicaldatamustbereviewedDeterminethetypeofpost-marketclinicalfollow-upstudytobeimplemented,ifapplicableReviewnewdata(i.e.literature,adverseevents,complaints,etc,)anddetermineifapost-marketclinicalfollow-upstudyisnecessarybasedonnewinformation(clinicalevaluation)MedicalAffairsRepresentativeReviewthePost-MarketClinicalFollow-UpJustificationformandPost-MarketClinicalFollow-UpPlanformtoconfirmthedecisionsregardingtheneedforapost-marketclinicalfollow-upstudyandclinicalfollow-upReviewandapprovetheclinicalevaluationperformedbytheResearchMana