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The CE Mark: Medical Devices & IVDs 2008

Date: Thursday, July 24, 2008

Location: Paradise Pier Hotel, Disneyland Resort; Anaheim, California USA

Overview:
 
All medical devices, including IVDs, must have a CE Mark in order to be sold in the European Union. This course will explain the process for obtaining CE Marks and discuss what must be done to comply with the EC Directives. It will discuss how to classify your device or IVD, how to select the best route to conformity, how to put together a technical file, and other strategies for obtaining a CE mark. Companies that understand these requirements will have a significant competitive advantage in obtaining rapid approvals in the European market. This course will be helpful in achieving compliance, receiving the CE Mark, and maintaining it. This course will be of interest to executives, regulatory affairs, engineering, marketing personnel, as well as, design engineers, and others involved in the CE Mark approval and documentation process or ISO 13485 compliance program.

What you will learn:

• The CE Mark approval process for medical devices & IVDs.
• Technical Regulations currently in effect & how to achieve compliance.
• How to classify your Device or IVD.
• What are the different "routes to conformity".
• Essential requirements and why they are critical to your submission.
• Common Technical Specifications (CTS) and what are they.
• Technical Regulations being written which will be required in the near future.
• Timing and schedule planning.
• How to prepare compliant documentation for Technical Files & Dossiers.
• What is the CE Mark impact of ISO 13485 on manufacturers.
• Differences between U.S. FDA and the European approval process.

Benefits of Attending:

• Meet the requirement for CE Marks to be on all new devices & IVDs being placed on the market in the European Community.
• Access the European Community and International Markets.
• Up to date information on directive revisions and CE Mark processes
• How to prepare compliant Technical files and Dossiers for the CE Mark.
• Determine the best route to conformity for your situation.
• Prevent delays during the approval process.
• Stay ahead of or keep up with your competitors.
• Understand the potential CE Mark impact of ISO 13485.

Abbreviated Outline:

• A. European Approval Process Overview- Guide to the CE Mark process
• B. Device Classifications & IVD Lists-Differences & How to determine
• C. ISO Standards & Revisions, EC Directives, MDD, IVD, AIMD, etc.
• D. Conformity Routes-How to select, benefits and potential problems
• E. Essential Requirements
• F. Technical Files, Dossiers; how to construct, Devices & IVDs
• G. Risk Management File-what is it and how to prepare
• H. Getting your CE Mark- step by step process to CE Mark approval
• I. Maintaining your approval- what is required for post approval vigilance
• J. Review and Summary

Speakers: Christine Ruther, Rebecca Pine

Registration & Additional Information : Airfare Discounts, Pricing, Discounts, Continuing Education Units Awarded, Speaker Biographies, Past Participants, Sights to see in the area.

On-line Registration Form Register on-line to reserve your seat now!

Early Summer is a gorgeous and popular meeting time in Southern California.

Be sure to reserve your space and room early!