• Evolving inspection paradigms, from planned visits to dynamic, risk-based regulatory oversight, and what that means for global medtech leaders
• Embedding inspection readiness into everyday operations, not just audit season, building systems that continuously demonstrate compliance
• Coordinating quality, regulatory, and clinical functions to present consistent, defensible evidence across the product lifecycle
• Leveraging data analytics and internal audit insights to anticipate inspection focus areas and prevent compliance gaps
• Case examples from Edwards Lifesciences’ global quality and audit program demonstrating readiness practices that scale across geographies and regulatory regimes