Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs
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Website https://compliance2go.com/product/?pid=CP2014-375 |
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Category Medical Device
Deadline: November 03, 2014 | Date: November 30, 2014
Venue/Country: Houston, U.S.A
Updated: 2014-10-21 18:52:53 (GMT+9)
Call For Papers - CFP
DESCRIPTIONWhy Should You AttendThis webinar is focused on understanding the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products. The course covers all relevant topics in brief associated with the Directives and Guidance Documents, the reasons behind their introduction and a review of methods for effective implementation.Key Topics to be Discussed:The current regulatory situation in relation to Medical Devices in the EU.The purpose of the Medical Device Directives.Meeting the New Requirements for Conformity Assessment by Product Type.Understanding the impact the Directive will have on developing and marketing new Medical Device products.An overview of key areas of the Directive:Scope of application and definitionEssential Device RequirementsMedical Device Type & Process PathMedical Device Technical FileClinical Investigation RequirementsClinical EvaluationsNotified Bodies involvementGain a detailed understanding of all Guidance Documents available to assist in the implementation of these directives.Detailed Agenda of the SessionDefinition: Medical Device or Personal Protective Equipment.Overview of the Global Medical Device IndustryStandardActive ImplantedIn Vitro DiagnosticCombination Products; Drug or Biologic + Device- Interface with Other Directives and How It’s Treated from a Regulatory PerspectiveAn Overview of the Medical Device Directives.Development, aims, implementation and update of the Medical Device DirectivesImplication of an EU Directive vs. RegulationMedical Devices (MDD), Active Implanted Medical Devices (AIMDD), In Vitro Diagnostic Medical Devices (IVDMD), Combination ProductsUpdate on the additional guidance documents relating to the directivesEssential RequirementsClassification of MD's and Process Implications Conformity AssessmentTechnical FileRelationship to EU Clinical Trial DirectiveGuidance Documents.Medical Device Directive Annexes.Compliance Requirements by TypeFull Quality Assurance SystemDeclaration of ConformitySafety.Medical Device Vigilance SystemManufacturer's RequirementsGMPGCPCE MarkingISO CertificationClinical TrialsLabelingISO Standard Certification.Overall process; Management Commitment & InvolvementRole of Notified BodiesRelationship to CE MarkingISO-13485 (Manufacturing) & ISO-14155 (Clinical Investigation & Evaluation) Overview, Conformity, Auditing and Harmonization to International StandardsISO-14155 Medical Device Clinical Investigations.Part I- Clinical StudiesPart II- Clinical InvestigationsLinkage to EU Clinical Trial Directive; What Does & Doesn't ApplyCompare & Contrast EU & FDA Procedures and Requirements.Process Similarities & DifferencesImplications for IndustryCompany ManagementProcess ChangesManagement Team EffectivenessRegulatory Approval and Liaison with Regulators.EU Co-Decision ProcedureCommittees, Working Parties Relevant for Medical DevicesWhen and How to Influence RegulatorsDo's and Don'ts of Regulatory InvolvementIndividual Company Involvement vs. Trade AssociationLearning ObjectivesUpon completion of this course attendees will have a thorough knowledge of the requirements for developing and marketing Medical Devices across the European Union. The Directives are complex and the requirements differ somewhat by Member State. The content of this course is designed to simplify the understanding of all requirements and to provide attendees with the latest information regarding interpretation and enforcement of these regulations.Who Will BenefitThis workshop will be of great value to Medical Device professionals and those involved in the registration of Medical Devices across the EU. It is primarily designed to benefit the following disciplines:Clinical research and medical operationsProject ManagersProduct Development personnelManufacturing personnelResearchers managing Medical Device R&D and DevelopmentQuality Assurance such as GMP, GCP AuditorsRegulatory affairsClinical trial supply personnelCRO personnelAll personnel who need to understand the procedures and impact of placing Medical Devices on the Market in the EU (30 expanded EEA countries)Webinar Includes:Q/A Session with the Expert to ask your questionPDF print only copy of PowerPoint slides90 Minutes Live PresentationCertificate
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