This Customer Complaint Procedure complies with ISO 13485:2016, EU MDR 2017/745, and FDA QMSR 21 CFR 820. Delivered in editable Word format, it defines processes for receiving, documenting, investigating, and resolving customer complaints to ensure regulatory compliance and product safety. Digital delivery within 24 business hours.


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This procedure ensures that customer complaints are handled consistently and effectively, with proper documentation and corrective actions. It covers complaint intake, investigation, root cause analysis, and resolution. Delivered in editable Word format for customization. Consultancy services are available via email, Zoom, or on‑site visits. Full implementation or signed, approved procedures are offered at an extra fee.