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.
Description
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
Objectives
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
Audience
Who Should Enroll:
Regulatory affairs managers, quality assurance managers and engineers, notified body and lead auditors, R&D engineers, and marketing managers are all welcome to participate in this course.
Prerequisite Knowledge/Requirements:
The following material is required:
- An understanding of the clinical evaluation requirements of Medical Device Directives 93/42 EEC and 90/385/EEC (and subsequent updates)
- MEDDEV 2.7.1
- Related NBOG documents