Getting to CE Mark, The Literature Route

In the EU a clinical trial may not be necessary.
A Clinical Evaluation, or literature review, is the assessment and analysis of literature data in order to verify the safety and performance of a medical device and determine if a clinical trial is necessary. The literature review procedure should begin early in the device development process and can help determine whether or not a clinical trial is necessary. This eConference is intended to demystify the process for Clinical Evaluation and clarify in what situations a clinical investigation will be required. If you are planning to to take your medical device to the EU marketplace you should have an understanding of this process.

Objective:

·  To understand the value of the Clinical Evaluation.

·  To understand when a Clinical Evaluation can be used.

·  To learn how to conduct a Clinical Evaluation.

 

You will receive:

·  A recording of the presentation

·  An Acrobat file of Mrs. Benaddi's slides.

·  The GHTF Study Group 5 proposed document on Clinical Evaluations.

·  0.15 CEUs.

Who should attend:
This eConference is designed for those who are involved in the development, manufacturing and marketing of medical devices.  It is particularly important to those who are tasked with performing a literature review/Clinical Evaluation and those involved in conducting medical device studies.   

Presenter:
Clinical Device Group is proud to present Mrs. Janette Benaddi RGN, BSc, MICR, MIOD. Janette Benaddi is the President and Managing Director of Medvance™ Ltd. Medvance provides consultancy in medical device clinical research and regulatory affairs. Janette has 17 years experience in managing medical device studies. Prior to founding Medvance almost 10 years ago, Janette worked for several medical device manufacturers in marketing, regulatory and clinical roles. Janette is a registered nurse has a BSc and Diploma in Management Studies, a diploma in Company Direction and holds a teaching certificate. She is a member of the Institute of Clinical Research and is currently chairman of the Institutes Medical Device Committee. Janette has published a number of articles related to medical devices and sits on several committees involved in the regulation and standardization of medical device studies. Mrs. Benaddi can be reached at janette@medvance.co.uk

The purchase is $401 for the CD. Event materials are available 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.