Understanding Clinical Evaluation for Notified Body and Regulatory Professionals
Understanding Clinical Evaluation for Notified Body and Regulatory Professionals
This suite provides detailed information on the 2 major components of clinical evaluation through existing data and prospective clinical investigation focusing especially on those aspects notified bodies will pay attention to when reviewing the clinical evaluation documents and as a consequence regulatory professionals should be prepared to apply. An optional module has been added providing a gap analysis between revision 3 and 4 of the MEDDEV 2.7.1.
ID: 123
70 minutes
1 trainings
| Course | ID | Duration | |
|---|---|---|---|
Clinical Evaluation Report: Review for Regulatory Professionals |
107 | 70 minutes |
Learning Objectives
These courses will enable notified body reviewers to master the strategic review points both when reviewing clinical evaluation reports from existing data as well as reviewing all important factors in the essential documents from a prospective clinical investigation. Likewise this course will provide regulatory professionals with clear understanding of their role in the clinical evaluation process. The optional module will provide both notified body reviewers and regulatory professionals an understanding of the changes brought by the revision 4 of the MEDDEV 2.7.1
Who Should Enroll
3rd Party Review Boards, Regulators and Regulatory professionals
Prerequisite Knowledge
Clear understanding of the clinical evaluation requirements of the Medical device directives 93/42 EEC and 90/385/EEC and consecutive updates, contents of MEDDEV 2.7.1 and related NBOG documents