FDA’s New Software Validation Requirements: Key Changes
May 19, 2026
The FDA’s new software validation requirements are transforming how medical and healthcare software is tested. By replacing outdated Computer System Validation (CSV) methods with Computer Software Assurance (CSA), the agency is prioritizing risk-based testing, automated validation, and real-world patient safety. Learn how the shift impacts Software as a Medical Device (SaMD), agile development, audit trails, quality management systems, and modern healthcare technology compliance.