The regulatory landscape for medical devices, in-vitro diagnostics (IVDs), and other healthcare technologies is evolving rapidly in 2025. These changes aim to enhance safety, sustainability, and innovation while ensuring businesses comply effectively with new requirements. This blog will walk you through key developments, including updated EU regulations on medical devices, batteries, AI, packaging, and substance…
By Shant Youkhana, Director of Quality and Strategic Solutions The Corrective and Preventative Action (CAPA) system is a regulatory requirement to which all Medical Device, Pharmaceutical, and Combination Product manufacturers must comply. Although there are minor differences between the CAPA system requirements in the Medical Device and Pharmaceutical industries, the overall purpose remains the same:…
