20 January 2010: MDD Revisions: An Overview of the Changes (Part 1: On-Demand now available)
27 January 2010: MDD Revisions: Risk Management and Clinical Evaluation (Part 2: On-Demand now available)
10 February 2010: MDD Revisions: Conformity Assessment Routes (Part 4: On-Demand now available)
17 February 2010: MDD Revisions: Vigilance and Post Market Surveillance (PMS) (Part 5: On-Demand now available)
23 February 2010: MDD Revisions: Preparing for an FDA Inspection and ISO13485 Audit—How to be Prepared for Both (Part 3: On-Demand now available)

9:00–10:30 am ET (15:00-16:30 CET)

The revisions to the European Medical Devices Directive (MDD) take effect March 2010. If your company manufactures medical devices for the European market, you should already have an implementation plan developed in order to achieve compliance in time. This is especially important because there will be no "grandfathering" for existing CE marked devices; companies that currently have a CE marking or are trying to earn a CE marking for new products are impacted by these revisions.

During this Webcast series, you will receive a thorough clarification of the revised European legislation, including details of the changes. Regulatory experts will provide insight and answer your questions on topics such as risk management, classification rules (including a discussion on software), clinical data requirements and postmarket review systems. You will gain practical tips on their implementation, up-to-date information on relevant guidance and standards, as well as learn what questions to ask your Notified Body.

This five-part series allows for extensive coverage, by multiple experts, of the changes to the MDD. Practical advice and examples from several points of view will provide a wide range of perspectives that can be applied to many highly individualized situations. Take advantage of this valuable opportunity to interact with experts and ask the questions that have troubled you and your organization as you have prepared for the revisions. You will walk away with the necessary information to plan for compliant implementation, allowing you to stay globally competitive, and have regulatory certainty as implementation commences.

Professional Levels: II, III

Who Should Attend:

• Medical device regulatory directors/managers
• Medical device quality directors/managers

Speakers:
Sunita Ahir, regulatory affairs manager, Premier Research Group SA
Karim Bagate, senior project manager, Premier Research Group SA
Gert Bos, PhD, head of regulatory and clinical affairs, BSI Group
Willibrord Driessen, Qserve® Group BV
William Greenrose, president, Qserve America Inc.
Miguel Hernandez, manager of vigilance, Premier Research Group SA
Ludger Möller, president, Medical Device Safety Service GmbH
James Pink, owner, Pink Associates
James Newman, scheme manager and product specialist, BSI Notified Body

Cost per Individual Session: Members: $295 USD (€195); Nonmembers: $395 USD (€265)
Complete Series: Members: $1250 USD (€840); Nonmembers: $1750 USD (€1165)
Cost is per site - unlimited participants!

Note: In order to ensure an effective Q&A session, registration will be limited to 100 sites. Be sure to register early.