Clinical Evaluation for Market Approval

Manufacturers planning to market their devices in Europe are now required to furnish clinical data in line with the new European Directives that came into effect as of March 21, 2010.
This intensely comprehensive 3 course suite on Clinical Evaluation for Market Approval and Clinical Trials will empower you with the essential information, requirements and guidelines you need to successfully and accurately conduct clinical evaluation under the new European Directives. From regulatory process and compliance to literature review and conformity; get on the right track to market approval today.
Course 1: Process and Regulatory Background
The first installment provides professionals with an expert overview of the new EU regulations and how they can positively impact global market access as well as a detailed outline of the necessary steps to follow to achieve immediate and lasting compliance of their clinical evaluation.
Course 2: Literature Review
Will show you how to effectively conduct a literature review according to the new MEDDEV guidelines; how to select and employ existing data from competitors and avoid or reduce the need to generate additional data through clinical studies. You will also discover how to successfully demonstrate compliance for approval of a clinical study, CE marking or post-market surveillance. You will learn how to generate valid clinical evidence to enhance device acceptance in routine medical practice as well as within the EU regulatory framework.
Course 3: Producing a Clinical Evaluation, Step by Step Primer
In the final course you will be taken through the new guidelines for clinical evaluation and learn the steps for producing your report - including presentation of device claims, criteria for predicate devices and concept of equivalence, as well as clinical data identification, critical assessment, selection and appraisal to determine conformity for CE marking or clinical trials.