This Non‑Conformity & Material Review Board (MRB) 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 identifying, documenting, and resolving non‑conforming products through MRB decisions. Digital delivery within 24 business hours.
This procedure ensures non‑conforming products are properly controlled and dispositioned. It covers identification, segregation, documentation, MRB review, and corrective actions. 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.