Classification of Medical Device in the European Union

Why take this eConference?
You'll see the complex process of device classification and how it leads to CE marking. 

Objective:
To provide guidance and examples of how to classify devices and address some of the grey areas that exist in device classification.

Who should attend:
- Device companies doing business in Europe.
- Clinical research managers.
- Regulatory Managers.
- FDA Regulators.
- CROs or IRBs working with European data.

You will learn:
- Hints and tips for determining if your device is Class I, IIa, IIb, or III.
- How to work through the rules and complex decision trees of device classification.

You will receive:
- Slides
- Examples
- EC Guideline on Classification of Medical Devices
- An expert speaker
- A chance to listen to other's Q&A
- CEUs & Certificate

Presenter:
Clinical Device Group is proud to present Janette Benaddi RGN, BSc, MICR, MIOD.

Ms. Benaddi is the CEO of Medvance™ Ltd. The company provides clinical research and regulatory consulting services to medical device, pharmaceutical and healthcare industries.

She has over 18 years experience of managing pre and post market clinical studies in both devices and pharmaceuticals.  Prior to founding Medvance almost 10 years ago, Janette 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. 

Ms. Benaddi is a registered nurse, has a BSc in Management studies, a Diploma in Company Direction, a Diploma in Management studies and also holds a teaching certificate.  She is a Board Director of the Institute of Clinical Research and is also currently Chairman of the Institutes Medical Device Committee. Janette has published several articles and sits on a number of committees involved in the regulation and standardization of medical device studies. Ms. Benaddi can be reached at janette@medvance.co.uk.

The purchase is $420 for OnDemand access and $470 for the CD. Event materials are available by download for OnDemand or are on the CD itself. Each attendee is eligible for 0.15 CEUs upon completing the course feedback via the link provided with the event materials. Click here to purchase.