美国医疗器械开发流程(FDA)

roussourcesrepresentinguserpreferences,customerfeedback,correctionaction,Engineering,ExecutiveManagement,Marketing,ClinicalDevelopment,etc.Cross-functionalreviewandapprovaloftheCustomerInputRequirementsduringthePlanningPhaserepresentsthestartofdesigncontrol.DuringthePlanningphaseaDesignandDevelopmentPlanandDesignHistoryFileareestablished.TheDesignandDevelopmentPlandetailsthedevelopmentresourcerequirements,developmentteamstructure,responsibilities,developmentscheduleandwhereappropriatethedevelopmentbudget.Preliminaryplansforverification,validation,manufacturing,andmarketintroductionmaybereviewedduringthePlanningPhase.KeyInputstoPlanningPhase•MCD•ProductRoadmap-OptionalDeliverablesfromPlanningPhaseICIR-ApprovedDDP-ApprovedDHF-EstablishedOptionalDeliverablesfromPlanningPhaseSRS-DraftUIR-Draft