Medical Devices: EU Directives, Guidance Documents, CE Marking Process, ISO Certification ……and the NEW Impending EU Regulations
Website https://www.demystifiedsolutions.com/trainingDetails/Medical-Devices-EU-Directives-Guidance-Document |
Deadline: May 23, 2017 | Date: May 23, 2017
Updated: 2017-03-10 15:30:15 (GMT+9)
Call For Papers - CFPThis Medical Device training will be discussing the newly-updated requirements of the Medical Device Directives and their linkage to the European requirements for CE Marking and ISO Certification on commercializing products. The history, current processes and latest regulatory environment on all Classes of Medical Devices and Combination Products will be discussed. Learn how to classify your product and how that classification translates to the required data needed to CE mark your product across the EU. You will also be updated on the recent and changes coming for the two NEW EU Medical Device Regulations , recently announced for final roll-out in 2017.Why Should You AttendThis course is focused on understanding the requirements of the Medical Device Directives / Regulations, their linkage to the EU Clinical Trial Regulation 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.Areas Covered in this WebinarDefinition: 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 StandardsCompare & Contrast EU & FDA Procedures and Requirements.Process Similarities & DifferencesImplications for IndustryCompany ManagementProcess ChangesManagement Team EffectivenessRegulatory Approval and Liaison with RegulatorsWhen and How to Influence RegulatorsDo's and Don'ts of Regulatory InvolvementLearning 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 Benefit :This 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 operations- Project Managers- Product Development personnel- Manufacturing personnel- Researchers managing Medical Device R&D and Development- Quality Assurance such as GMP, GCP Auditors- Regulatory affairs- Clinical trial supply personnel- CRO personnel- All personnel who need to understand the procedures and impact of placing Medical Devices on the Market in the EU (30 expanded EEA countries)For More Info, Please Click below URL:https://www.demystifiedsolutions.com/trainingDetails/Medical-Devices-EU-Directives-Guidance-Documents-CE-Marking-Process-ISO-Certification-……and-the-NEW-Impending-EU-Regulations-DEMY051453
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