Description
The course provides detailed review of the new requirements introduced by the MEDDEV 2.7.1 rev 4 compared to the revision 3. In addition to this gap analysis between the two revisions, the new elements of the European Medical Device Regulation (MDR) have also been included. The course helps notified body reviewers understand the essential new elements that both MEDDEV 2.7.1 rev and the MDR bring.
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 additional requirements introduced by the rev 4 of the MEDDEV 2.7.1 and MDR
- Master the strategic review points from clinical evaluation reports using existing data
- Understand the process of accurate positioning of a new medical device compared to the existing standard of care
- 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