Strategies to Prepare for Combination Products Regulatory Audits

Description

This whitepaper provides strategic guidance for preparing combination product manufacturers for regulatory audits in 2024-2025. It addresses regulatory intelligence and cross-center coordination, Quality Management System evolution with QMSR incorporating ISO 13485:2016 (effective February 2, 2026), and cybersecurity as a core quality requirement per FDA’s June 2025 final guidance. The document covers design controls and manufacturing excellence, human factors engineering per FDA’s September 2023 guidance, post-market surveillance and real-world evidence, validation and verification excellence, labeling compliance and UDI requirements, training programs, and strategic mock audits. It emphasizes that QMSR represents the most significant quality system regulatory shift in three decades, requiring proactive organizational transformation. Includes case study of drug-eluting stent manufacturer demonstrating successful remediation and audit readiness.