Audio Conference

Industry Update: Revisions to the Medical Devices Directive Helen Colquhoun, MD CEO Pleiad Devices Purchase recording US$199

Register for this Audio Conference

Due to the widely held view that certain aspects needed to be clarified, the EU Medical Devices Directive (MDD) is being revised. A number of proposed revisions have been under consideration for over a year now. Among the likely changes, there will be an increased demand for clinical data and post-market surveillance. In this audio conference, Dr. Helen Colquhoun will provide an update on the review progress, and describe the revisions, giving detail on those of greatest importance to device companies.

This audio conference will cover:

• The current status of implementation of revisions to the Medical Devices Directive
• Details of the more important revisions, particularly those pertaining to clinical data and post-market surveillance
• The implications these revisions will have for medical device manufacturers, whether based in the USA or EU

About the speaker:

Helen Colquhoun holds degrees in Genetics and Medicine from the University of Edinburgh and spent several years practising clinical medicine before entering the life science industry in 1988. Initially working in the UK in the pharmaceutical industry, Helen set up as an independent consultant in 1995. Since that time she has spent increasingly more time working with medical device and drug delivery companies in the USA and EU. In 2000 she co-founded the Pleiad group of companies and is currently CEO of Pleiad Devices, a clinical research organization based in the USA and Europe that specializes in clinical research and regulatory support for medical device companies. Helen runs Pleiad's North American operation and is based in Cambridge, Massachusetts.

Who should attend?

• Regulatory Associates/Managers
• Clinical Research Associates/Managers
• Product Development Managers
• Marketing Executives
• Senior/Operational Management Team Members

This audio conference is classified as General Interest.

Registration Options

• Purchase a recording of this event $US199

Home | About | Services | News | Clients | Careers | Resources | Contact | Search

Offices in Boston, Denver, Halifax, Madrid, and Providence

Copyright © 1998-2007, ForeignExchange Translations, Inc. All rights reserved.