Description As the transition from MDR/IVDR 1.0 to 2.0 reshapes expectations for clinical and clinical performance evidence, real-world evidence (RWE) is gaining attention but remains underutilized in practice. Many manufacturers struggle with questions such as where to start, how to scale, and how to ensure real-world data (RWD) delivers tangible regulatory and business value. This session provides practical guidance for designing lean, fit-for-purpose RWE strategies that align with evolving regulatory expectations across the product lifecycle. We will demonstrate how to embed RWD collection from early development through post-market activities, translating regulatory and clinical questions into actionable data strategies. Through real-world examples, we'll highlight what works, common pitfalls, and how to adjust early while maintaining efficiency and regulatory relevance. You'll leave with clear, actionable approaches to transform existing real-world data into a credible, decision-ready component of their evidence portfolio.
Learning Objectives:
Identify how to translate regulatory and clinical questions into effective real-world data strategies across the product lifecycle.
Apply practical approaches to design and implement scalable, fit-for-purpose RWD collection that supports regulatory decision-making.
