ISO 13495 Gap Closure & Harmonization

Service Description

HeurNova provides structured, risk-based consulting to close compliance gaps and harmonize Quality Management Systems with ISO 13485:2016 and FDA 21 CFR 820 / QMSR requirements. We perform a comprehensive gap analysis of your existing quality system, identifying deficiencies and redundancies across documentation, design controls, risk management, validation, and post-market processes. We then develop a tailored Gap Closure Plan — prioritizing corrective actions by regulatory risk and operational impact — and guide implementation through document updates, training, and system verification. Deliverables include: Full QMS Gap Assessment Report with risk-weighted findings Corrective Action Plan with closure timeline Updated procedures and records aligned with ISO 13485 and QMSR Cross-reference matrix linking each ISO 13485 clause to FDA requirements The result: an efficient, harmonized QMS that meets international expectations and is audit-ready for both FDA and Notified Body inspections.