Design Verification

Service Description

HeurNova provides comprehensive Design Verification Consulting to ensure that medical device designs meet defined input requirements and regulatory expectations. Our approach integrates ISO 13485, ISO 14971, and FDA 21 CFR 820.30/QMSR requirements to verify design conformity through objective, documented evidence. Services include: • Development and review of Verification Plans, Protocols, and Reports • Traceability Matrix creation linking design inputs, verification activities, and outputs • Test method validation and statistical justification (per ISO/TR 24971 and GHTF guidance) • Data analysis, deviation management, and report authorship • Integration with FMEA and risk-control verification Deliverables are inspection-ready and structured to withstand notified-body and FDA scrutiny — ensuring that design intent is fully proven before transfer to validation and production.