Audio Conference

The Revised MDD: Practical Implications for Device Manufacturers Helen Colquhoun, MD CEO Pleiad Devices Purchase recording US$199

Purchase recording of this Audio Conference

The Medical Devices Directive (MDD), which sets down the rules and regulations for marketing medical devices in the EU, is in the final stages of a lengthy revision process. The general consensus is that the directive has been working well to date, but that certain aspects need to be tightened up. To this end, there are no radically new requirements, but there will be an increased demand for clinical data and post-market surveillance. What will this mean for medical device manufacturers? In this audio conference, Dr. Helen Colquhoun will summarize the revisions and describe in detail those with the greatest potential impact. She will discuss the implications of these revisions for medical device manufacturers, illustrating points with practical examples and using different scenarios to explain how best to approach the issues raised.

This audio conference will cover:

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

About the speaker:

Helen Colquhoun, MD holds degrees in Genetics and Medicine from the University of Edinburgh and spent several years practicing 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 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/Product Managers
• Senior/Operational Management Team Members

This audio conference is classified as General Interest.

Purchase Options:

• Purchase recording $US199

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