* . PMS under MDR - Practical implementation - PSUR creation - Timing/content (including usage, patient population) - Getting the Information needed - Defining roles and responsibilities between departments/functions - PROCESS for Assessing/Analyzing the data and drawing conclusions, holistically, across various data sources - Connecting with other plans and reports in the QMS; - Timing and connection with CER (per class) * . Vigilance reporting - new definitions - new timelines - managing info from EOs - changes to process/software - reporting thru Eudamed * . Maintaining responsibilities after product obsolescence (implants, capital equipment, and in general)