With the recent amendments to the EU medical devices directive (MDD), there is much more emphasis being placed on the clinical evaluation process, and how this should be appropriately conducted. Indeed, in Europe it is now mandatory to conduct a clinical evaluation for some classes of medical device. In this presentation, our speaker reviews everything you need to know to be able to conduct a systematic literature review/clinical evaluation for your products, and prepare a report that will satisfy your Notified Body.

This audio conference is designed specifically for those involved in gathering clinical evidence and conducting clinical evaluations to support the regulatory approval and marketing of medical devices. It should be of particular interest to those involved in collating clinical evidence, including regulatory and clinical staff conducting literature reviews/clinical evaluations. It will also be of use to staff working in quality departments and research and development departments.

This audio conference covers:

• Regulatory references and background to clinical evaluation
• The process for determining the need for clinical data
• Conducting a literature review, what exactly does this involve
• Best practices for online searching
• How to write a clinical evaluation report that will be acceptable to the notified body

About the speaker:

Janette Benaddi, RGN, BSc, MICR, CSci, CDir is the CEO of Medvance Ltd, providing clinical research and regulatory consulting services to the medical device and healthcare industries. She has over 24 years of experience managing pre- and post-market clinical studies in both devices and pharmaceuticals. Prior to founding Medvance 12 years ago, she worked in Paris for a medical device consultancy group as Project Director in Clinical/Regulatory Affairs. Janette has also worked with several multinational organizations in various clinical, regulatory and marketing roles. She has extensive experience of conducting clinical studies with medical device products.

Janette is a registered nurse, has a BSc in Management Studies, a Diploma in Company Direction, a Diploma in Management studies, holds a teaching certificate and is a Chartered Scientist and Chartered Director. She is the Chair of the Board of Directors at The Institute of Clinical Research in the UK and is also currently Chairman of the Knowledge Transfer Network Clinical Studies Special Interest Group. Janette has published several articles and sits on a number of committees involved in the regulation and standardization of medical device studies.

Who should attend?

• Clinical Research Associates
• Clinical Coordinators
• Clinical Project Leaders
• Regulatory Departments
• Quality Departments
• R&D Departments