New Software Validation Requirements: Medical Apps
May 19, 2026
Discover how the FDA’s new software validation requirements are making medical apps safer and more reliable. Learn how Computer Software Assurance (CSA) is replacing traditional Computerized System Validation (CSV) with risk-based testing, critical thinking, unscripted validation methods, secure audit trails, and continuous post-market surveillance. Explore how Software as a Medical Device (SaMD), 21 CFR Part 11 compliance, GAMP 5, and modern pharma validation software are shaping the future of trusted digital healthcare.