Obtaining and Maintaining EU Compliance Under the Medical Device Directive

May 16, 2011 by
Filed under: Organic Reviews

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Obtaining and Maintaining EU Compliance Under the Medical Device Directive

Why You Should Attend:

Medical devices cannot be shipped to Europe unless they are in full compliance with the Medical Device Directive. The compliance burden is very different depending on the classification of the device.

This session will cover the Technical File and Essential Requirements document, in which design documentation must be maintained; unless you are intimately familiar with the requirements in advance, this could be a serious compliance issue. Also contained will be the recent changes to the MDD, noncompliance with which opens the possibility of cessation of certification. Also, unlike domestic (US) regulations, the MDD requires clinical data – methods for gathering this data will be reviewed. Notified body selection is a critical aspect of MD compliance – this webinar will share some tips and provide experience in this area.

Areas Covered in the Seminar:

Device classification distinctions, and what that means to you in terms of compliance burden.
Technical File contents and organization.
Review and selection of your notified body.
How to show compliance with the Essential Requirements.
Changes to MDD and their implications.
What is expected for clinical data.

Who Will Benefit:

This webinar will provide valuable assistance to all device manufacturers who wish to sell product in the European Community. The employees who will benefit include:

Top management
Regulatory management
Quality Management
Sales and Marketing Management
Quality Engineers
Other personnel involved in development and implementation of the QMS

Instructor Profile:
Jeff Kasoff, RAC, is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. Jeff is responsible for oversight of corporate compliance with domestic and international regulations, preparation of submissions, and is primary liaison with regulatory agencies and notified bodies.

For More Details:

http://complianceonline.com/ecommerce/control/trainingFocus/~product_id=701789?channel=articlesbase

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