RGA 6685 — European Medical Device Regulations

3 semester hoursGraduateLecture

Covers European Commission directives and guidance documents; European Agency for the Evaluation of Medicinal Products, medical device guidance documents, and notified body guidelines and recommendations; Global Harmonization Task Force final reports; and mutual recognition agreements. Topics include biological and biotechnological products, Conformité Européenne marking, conformity assessment and notified bodies, the Global Harmonization Task Force, clinical trials, and standardization.

Prerequisites

Links

Official catalog (RGA course descriptions) · All RGA courses · Plan it at numap.app