This e-learning course provides detailed insight into clinical evaluation report reviews by notified body reviewers.
Description
This e-learning course provides detailed insight into clinical evaluation report reviews by notified body reviewers. It particularly focuses on the aspects of clinical evaluation reports that notified bodies pay attention to during the reviewing process.
The course complies with the requirements of the Medical Device Directives as well as the Medical Device Regulations, MEDDEV 2.7.1 rev 4 and the NBOG checklist for auditing clinical investigations.
Objectives
Upon successfully completing this course, learners will be able to:
- Master the strategic review points from clinical evaluation reports using existing data
- Know how to cross check the clinical evaluation report with other essential documents in the technical file
- Review the risk management considerations of manufacturers.
- Examine the validity of report conclusions including provisions for post market surveillance
- Ensure conclusions comply with essential requirements
- Gain a clear understanding of their role in the clinical evaluation process
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 encouraged to enroll 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 rev 4
- Medical device regulations
- Related NBOG documents