Regulatory Shifts in SaMD: Why Agile Infrastructure Matters More Than Ever
Introduction: The Changing Landscape of SaMD Software as a Medical Device ( SaMD ) has rapidly evolved from a niche innovation to a core pillar of modern digital healthcare. With growing adoption in diagnostics, monitoring, and therapeutics, regulatory authorities like the FDA (U.S.) , EMA (Europe) , and MHRA (U.K.) are continually updating frameworks to ensure patient safety and software reliability. However, these evolving regulations also create complexity for developers and manufacturers. To keep up, organizations must prioritize agile, compliant infrastructure that supports rapid iteration without compromising quality or compliance. Regulatory Shifts in SaMD 1. Understanding SaMD’s Regulatory Evolution Initially, medical software was treated like a static product—one that underwent lengthy validation and certification before release. But as cloud, AI, and machine learning became integral to healthcare applications, software began updating frequently. This shift challe...