The plan for collecting and analysing information about the device once it is on the market: data sources, methods, indicators, thresholds, responsibilities and reporting.
Plan Work product in the Medical electronics and medical device chips lifecycle
Regulations require manufacturers to monitor their devices in use and act on what they find. The plan makes that systematic; without it, signals are noticed late, trends are missed and regulators find the surveillance system inadequate.
The full lifecycle detail, with its charts, flows, tables and every section, is for registered members. Registration is free and takes a minute. You come back to this page afterwards.