EU MDR article 88 (Trend Reporting) asks manufacturers to report 'any statistically significant increase in the frequency or severity of incidents that are not serious incidents...etc'.
I am raising this here as there is clearly an overlap between 'incidents' and 'complaints' and that some form of metric of incidents has to be monitored to look for a 'statistically significant increase'?
I'm interested how others manage this?
I am raising this here as there is clearly an overlap between 'incidents' and 'complaints' and that some form of metric of incidents has to be monitored to look for a 'statistically significant increase'?
I'm interested how others manage this?