* . 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)