In the digital health revolution, Software as a Medical Device (SaMD) is at the forefront — reshaping how healthcare is delivered, regulated, and scaled. As AI technology matures, the combination of AI and SaMD is creating unprecedented opportunities to diagnose, treat,…
Making Software as a Medical Device (SaMD) Safe, Effective, and Compliant
Developing Software as a Medical Device (SaMD) is more than just writing code — it involves meeting strict regulations to ensure patient safety, clinical accuracy, and legal compliance. Here are the key best practices to get it right: 1. Understand the…