Audio Conference

Clinical Evaluations for Medical Devices: the Literature Route Helen Colquhoun, MD CEO Pleiad Devices Purchase recording US$199

Register for this Audio Conference

Evaluation of clinical data is a necessary part of the European technical file or design dossier for CE marking medical devices. The purpose of the evaluation is to demonstrate conformity with the essential requirements concerning performance and safety of the device under normal conditions of use. The data may come from published literature, a clinical trial or a combination of the two. This audio conference will focus on the literature route for providing clinical data, which, if done well, may preclude the need for a de novo clinical trial. The presentation will highlight pitfalls and best practices, and describe proposed MDD revisions concerning clinical evaluations.

This audio conference will cover:

• When a literature review alone is enough to provide clinical data for the technical file/design dossier
• The optimal way to perform a literature review and keep your notified body happy (avoiding issuance of non-conformities)
• Using the literature review as a tool for product development
• How revisions to the MDD are likely to place even more importance on clinical evaluations

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 Helen co-founded Pleiad and is now CEO of Pleiad Devices, a clinical research organization that specializes in clinical evaluations for medical device companies. She is based in the USA and runs Pleiad's North American operations.

Who should attend?

• Regulatory specialists
• Regulatory managers
• Product development managers
• Clinical managers
• Medical writers
• Information scientists

This audio conference is classified as General Interest.

Registration Options

• Purchase CD or download $US199

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