Directive 2007/47/EC was passed in late 2007. This Directive amends two of the Medical Devices Directives and there are important changes for which you should plan before they become mandatory in March 2010. To update clients on this and other issues related to Europe, we are planning our second annual “Emergo Client Workshop.”   The workshop will take place on:

THURSDAY, MAY 15
8:30AM to 4:00PM
Emergo Group headquarters
Austin, Texas

This full day workshop is open to Emergo clients only and will cover these topics:

Overview of CE Marking
- Refresher on how CE Marking works in Europe
- Background on the Medical Devices Directive MDD 93/42/EEC
- Other places outside Europe where CE Marking makes obtaining regulatory approval much easier
- Related Directives: Electromagnetic Compatibility (EMC), Low Voltage and Personal Protective Equipment (PPE) Directives.

Upcoming changes to the MDD and how they affect you!
- In depth discussion of the newly adopted changes driven by Directive 2007/47/EC and their impact on the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC).
- Discussion about new clinical evidence requirements. Are you in compliance? 

Tips on Technical File compilation
- A refresher on best practices for compiling a Technical File
- Overview of the Essential Requirements checklist

Labeling and languages issues
- How to use EU harmonized symbols in EN 980 to avoid unnecessary translations and confusion.
- Common errors and how to avoid them
- Real life examples of excellent Instructions for Use and labels

Post marketing surveillance
- Update on recent changes to reporting timelines
- Changes in terminology
- New Notified Body and Competent Authority Guidance Documents and how they might affect your post marketing surveillance procedures. 
 
The workshop is limited to 10 participants. If you are unable to attend on May 15, let us know as we may open a second date in June if demand is strong. You will be given a Certificate of Completion. Here are the details:

Cost:
Only US$395 per person.

Who should attend:
Anyone who has direct responsibility for maintaining regulatory compliance for your company.

The presenter:
Evangeline Loh, PhD RAC (US, EU)
Director of Regulatory Affairs
http://www.emergogroup.com/AboutUs/EmergoTeam.asp#evangeline

Hotel:
Suites are available for $158/night at the Radisson Hotel in downtown Austin. You can reserve online by going to http://www.radisson.com/austintx and entering the word "EMERGO" in the Promotional Code field to get the discounted rate. You can also call the hotel directly at 1.512.478.9611 and mention “Emergo Group.”

Transportation:
Shuttle service will be provided from the hotel to Emergo Group on Thursday morning, and from Emergo Group to the hotel on Thursday afternoon. You are responsible for arranging transportation between the airport and hotel. If you need a ride directly to the airport on Thursday afternoon, we can call a taxi for you. A taxi to or from the airport to the Radisson downtown should cost $20-25. Plan on 30 minutes from Emergo to the airport.

Questions?
If you are interested in attending, please call us toll-free at 1.800.956.6588 and ask for Joelene. My email is joelene@emergogroup.com. Payment by company check or credit card is accepted. To pay online, go to http://www.emergogroup.com/securepayment.asp and enter “Workshop” in the field that says Invoice #. We look forward to seeing you in Austin!

Best Regards,

Joelene Geranios
Emergo Group, Inc.

P.S. We will also be doing full day workshops on Risk Assessment in mid September and Clinical Evaluation Reports in early November. Exact dates to be determined. If you are interested in these, please let us know.