Data from Prospective Clinical Investigation for CE Mark E-Learning with WMDO

The course provides detailed insight into clinical investigation reviews for both the CE-Mark and post-market surveillance program. It particularly focuses on the aspects of clinical investigation reviews that notified bodies pay attention to during the reviewing process.

This course complies with the requirements of the Medical Device Directive MEDDEV 2.7 as well as the NBOG checklist for auditing clinical investigations.

To enroll and purchase this course, please visit the WMDO website at: http://www.wmdo.org/SGS.aspx

Upon successfully completing this course, learners will be able to:

• Understand the objectives of clinical investigations
• Draw meaningful conclusions from the results of clinical investigations
• Communicate to notified body reviewers which essential points they should look for during audits of clinical investigation files
• Comply with the requirements of MEDDEV 2.7 and the NBOG checklist
• Prepare for notified body audits by recognizing notified bodies’ specific focus points