End-to-End Risk Management

Service Description

HeurNova delivers comprehensive risk management consulting covering the full product lifecycle — from FMEA development to complete ISO 14971:2019-compliant documentation. Our approach integrates design, process, and system-level risk analyses with regulatory expectations under ISO 13485, ISO/TR 24971, and the FDA QMSR. We facilitate cross-functional risk workshops, develop and maintain risk files, and ensure full traceability between design inputs, verification activities, and post-market surveillance data. Deliverables include risk management plans and reports, design and process FMEAs, hazard analyses, fault trees, risk control verification matrices, and post-production monitoring strategies — all built to withstand notified-body and FDA audit scrutiny.