Module6 May 20264 min read
Module spotlight: Complaint Handling
A complaint is a signal from the real world. Complaint Handling captures it, assesses it, and connects it to the investigation, CAPA, or vigilance report it may require.
By MoniDoseQMS Team
Every complaint is information you cannot get any other way — how your product behaves in real use, in real hands. Complaint Handling makes sure that signal is captured, assessed, and acted on, rather than lost in an inbox.
What you can do
- Log complaints and customer feedback in a structured record
- Assess severity and whether the complaint is reportable
- Link a complaint to an investigation, CAPA, or vigilance report
- Feed real-world data back into risk and post-market surveillance
Why it matters
ISO 13485 §8.2.1 and EU MDR vigilance obligations both hinge on handling complaints properly. Connecting complaints to risk, CAPA, and surveillance means a single report can trigger exactly the response it should — including a regulatory report when one is required.