Building on the MDR and pharmacovigilance foundation of the Introductory level, this Advanced course develops the European, analytical and corrective disciplines that complete a post-market surveillance program.

This 32-hour Professional Certificate Course covers EU MDR post-market surveillance (Articles 83–92) with vigilance and PSUR, signal detection and trend analysis with statistical methods, CAPA integration under 21 CFR §820.100, and recall classification (Class I/II/III) and field safety corrective actions.

By the end, participants have produced a recall-classification memo, a post-market surveillance plan element and an identification of PSUR requirements under EU MDR for a given device class.

The Advanced course connects EU MDR vigilance, signal detection, CAPA and recalls into an integrated surveillance program, preparing participants for post-market surveillance and vigilance roles.

Participants who meet the course completion requirements receive a Certificate of Completion issued by Aleph University.