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    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 | Want to Edit it Edit Freely

    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

    DESCRIPTION

    Why Should You Attend

    This 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 definition

    Essential Device Requirements

    Medical Device Type & Process Path

    Medical Device Technical File

    Clinical Investigation Requirements

    Clinical Evaluations

    Notified Bodies involvement

    Gain a detailed understanding of all Guidance Documents available to assist in the implementation of these directives.

    Detailed Agenda of the Session

    Definition: Medical Device or Personal Protective Equipment.

    Overview of the Global Medical Device Industry

    Standard

    Active Implanted

    In Vitro Diagnostic

    Combination Products; Drug or Biologic + Device- Interface with Other Directives and How It’s Treated from a Regulatory Perspective

    An Overview of the Medical Device Directives.

    Development, aims, implementation and update of the Medical Device Directives

    Implication of an EU Directive vs. Regulation

    Medical Devices (MDD), Active Implanted Medical Devices (AIMDD), In Vitro Diagnostic Medical Devices (IVDMD), Combination Products

    Update on the additional guidance documents relating to the directives

    Essential Requirements

    Classification of MD's and Process Implications

    Conformity Assessment

    Technical File

    Relationship to EU Clinical Trial Directive

    Guidance Documents.

    Medical Device Directive Annexes.

    Compliance Requirements by Type

    Full Quality Assurance System

    Declaration of Conformity

    Safety.

    Medical Device Vigilance System

    Manufacturer's Requirements

    GMP

    GCP

    CE Marking

    ISO Certification

    Clinical Trials

    Labeling

    ISO Standard Certification.

    Overall process; Management Commitment & Involvement

    Role of Notified Bodies

    Relationship to CE Marking

    ISO-13485 (Manufacturing) & ISO-14155 (Clinical Investigation & Evaluation) Overview, Conformity, Auditing and Harmonization to International Standards

    ISO-14155 Medical Device Clinical Investigations.

    Part I- Clinical Studies

    Part II- Clinical Investigations

    Linkage to EU Clinical Trial Directive; What Does & Doesn't Apply

    Compare & Contrast EU & FDA Procedures and Requirements.

    Process Similarities & Differences

    Implications for Industry

    Company Management

    Process Changes

    Management Team Effectiveness

    Regulatory Approval and Liaison with Regulators.

    EU Co-Decision Procedure

    Committees, Working Parties Relevant for Medical Devices

    When and How to Influence Regulators

    Do's and Don'ts of Regulatory Involvement

    Individual Company Involvement vs. Trade Association

    Learning Objectives

    Upon 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)

    Webinar Includes:

    Q/A Session with the Expert to ask your question

    PDF print only copy of PowerPoint slides

    90 Minutes Live Presentation

    Certificate


    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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