This Data Analysis Procedure complies with ISO 13485:2016, EU MDR 2017/745, and FDA QMSR 21 CFR 820. Delivered in editable Word format, it defines requirements for collecting, analyzing, trending, and interpreting quality and performance data to support continuous improvement and regulatory compliance. Digital delivery within 24 business hours.
This procedure outlines methods for data collection, statistical analysis, trend evaluation, and reporting of quality indicators. It supports management review, CAPA effectiveness checks, supplier monitoring, complaint trending, and process performance evaluation. Delivered in editable Word format for easy customization. Consultancy support is available via email, Zoom, or on‑site visits. Full implementation or signed, approved procedures are available for an additional fee.