The new era of SaMD: Why cloud infrastructure is the foundation for digital health in 2026

The healthcare industry is shifting towards proactive, prognostic learning systems, requiring a reimagining of how to demonstrate control. Cloud infrastructure has become a superior foundation for regulated medical software, driven by the FDA's QMSR transition and the EU AI Act. Manufacturers must adopt Compliance as Code to automate document control and change management. This shift is a regulatory necessity, not just a competitive advantage. Cloud infrastructure is key to meeting international harmonization and risk-based oversight requirements.