Clinical Evaluation Report: Review for Regulatory Professionals
Course Description:
The course provides detailed insight into clinical evaluation report reviews by Notified Body and Regulatory reviewers. It particularly focuses on the aspects of clinical evaluation reports that notified bodies and regulatory authority reviewers pay attention to during the reviewing process.
The course complies with the requirements of the Medical Device Regulations, MEDDEV 2.7.1 rev 4 and the NBOG checklist for auditing clinical investigations.
Learning Objectives:
Upon successfully completing this course, learners will be able to:
- Master the strategic review points from clinical evaluation reports
- 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 the General Safety and Performance Requirements of the EU-MDR
- Gain a clear understanding of their role in the clinical evaluation process
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:
- MEDDEV 2.7.1 rev 4
- EU Medical device regulations
- Related NBOG documents