Root Cause Investigation Support

Service Description

HeurNova provides structured, data-driven investigation support for nonconformances, CAPAs, deviations, and product complaints in compliance with ISO 13485, ISO 14971, and 21 CFR 820/QMSR requirements. Our approach integrates risk management, FMEA methodology, and evidence-based analysis to identify true root causes—not just symptoms. We develop investigation plans, perform data trending, facilitate failure analysis, and prepare documentation that meets FDA and Notified Body expectations. Deliverables include investigation reports, 5-Why and Fishbone analyses, risk linkage evaluations, and CAPA effectiveness checks—all traceable within your QMS framework. HeurNova ensures findings translate into measurable preventive action and lasting system improvement.