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