2012 - Changes in the EU Medical Device Directives; 2010 Modifications and the 2012 Recast of the MDD Directives - Webinar By GlobalCompliancePanel

Overview: 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.

This Medical Device Directive training will be discussing the recently implemented and currently planned changes to the Medical Device Directives across the EU. It includes specific insight from direct involvement and work within the EU and the Commission's major improvement objectives to their system today. Specific targeted areas for change is discussed as well as the likely implementation timetable.

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 Requirements
Medical Device Type & Process Path
Medical Device Technical File
Clinical Investigations
Clinical Evaluations
Notified Bodies
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 Global Medical Device Industry
Standard
Active Implanted
In Vitro Diagnostic
Combined Medicinal / Device- Interface with Other Directives
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), Combined Medicinal / Medical Device Products
Update on the additional guidance documents relating to the directives
Essential Requirements
Classification of MD's and Process Implications / Path by Device Type
Conformity Assessment
Technical File
Relationship to EU Clinical Trial Directive
2009-2010 Changes from Directive 2007 / 47 / EC
Current Perceived Problems (by the Commission) with the Current CE Marking Registration System and Notified Body Auditing Structure
Correction Options Laid Out by the European Commission
Feedback Received from Stakeholders
Who will benefit:
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

Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00

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http://www.globalcompliancepanel.com

Phone: 800-447-9407
Fax: 302-288-6884