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CE Marking: Medical Devices, IVDs, & AIMDs 2011

• Date: Thursday, October 27, 2011
• Location:Embassy Suites on the Bay , Burlingame, California USA (near San Francisco International Airport (SFO))

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, active implants & IVDs.
• Technical Regulations currently in effect & how to achieve compliance.
• Recent changes to directives and how to comply.
• 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.
• Timing and schedule planning.
• How to prepare compliant documentation for Technical Files & Dossiers.
• How to prepare for the ISO 13485 & CE audit.

Benefits of Attending:

• Learn the requirement for CE Marking devices & IVDs.
• Access the European Community.
• Hear up to date information on directive revisions and CE Mark processes
• Learn how to prepare compliant Technical files and Dossiers.
• See how standards fit into the technical documentation.
• 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 relationship between CE Marking and ISO 13485.

Abbreviated Outline:

• A. CE Mark Overview
• B. Classification & Conformity Assessment Routes
• C. Creating a Technical File / Design Dossier
• D. Understanding and Meeting the Essential Requirements
• E. The Notified Body Audit
• F. Guidance Documents (including vigilance)
• G. Maintaining Technical Files / Design Dossiers
• H. Overview of Other Directives to Consider
• I. 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!