Most medical device complaint systems can prove that a case was handled. Far fewer can prove that the organisation understood what the case was trying to reveal.
In medical device organisations, complaint handling is often built around intake, investigation, documentation, and closure. But a complaint may be more than a quality record. It may be the earliest structured signal that device performance is changing, a user workflow is breaking down in real-world conditions, labeling is unclear, servicing is inconsistent, or a risk control is not performing as expected.
This Freyr white paper explores how manufacturers can move from reactive complaint administration to signal-led post-market surveillance. It examines intake quality, triage, seriousness and reportability decisions, investigation depth, root-cause linkage, coding consistency, AI-enabled signal detection, complaint trending, escalation, and the connection of complaint outputs to vigilance, CAPA, risk management, and inspection readiness.
Because the true measure of complaint maturity is not how quickly cases are closed. It is how quickly an organisation can move from complaint capture to signal recognition, from signal recognition to decision, and from decision to control.
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