In this episode of the ARCS Cognitio Podcast, we explore the regulatory framework for in vitro diagnostic (IVD) medical devices with international regulatory affairs expert Dr Adel Schneider.

IVDs—from pregnancy tests to advanced blood screening assays—play a critical role in healthcare by providing the information that guides diagnosis and treatment. But how do regulators ensure these devices are safe, reliable, and trustworthy?

Dr Schneider takes us through the key elements of IVD regulation, including definitions, classifications, essential principles, clinical evidence, quality systems, and post-market surveillance. With more than 30 years’ experience working across Europe, Asia Pacific, the Middle East and Africa, she offers a clear overview of the global regulatory landscape and why trust in IVDs is so vital.

Join us as we unpack the complexities of IVD regulation and its impact on patients, professionals, and the broader life sciences community.