QMS Development

Service Description

HeurNova designs and implements risk-based Quality Management Systems (QMS) aligned with ISO 13485, 21 CFR 820/QMSR, and global medical-device regulatory frameworks. We develop QMS architectures tailored to each organization’s size, product risk class, and operational maturity. We create and optimize quality manuals, procedures, forms, and records that ensure compliance while maintaining operational efficiency. Whether establishing a system from the ground up or rebuilding legacy processes, we focus on traceability, risk integration, and lifecycle control. Deliverables include a complete QMS framework with SOPs, documentation maps, and audit-ready templates designed to meet ISO 13485 and FDA QMSR requirements.