The medical device industry is increasingly reliant on digital technologies—automation tools, analytics platforms, robotics, cloud-based applications, and AI/ML. With this change comes the need for a modernized approach to validating and assuring software used in production and the quality management system. The FDA’s updated Computer Software Assurance (CSA) guidance, issued on February 3, 2026, provides a flexible, risk-based, least-burdensome framework designed to ensure patient safety and product quality without unnecessary overhead.
This article summarizes the key aspects of CSA and explores how manufacturers can determine the appropriate level of assurance activities—from scripted to unscripted, ad‑hoc, and exploratory testing—based on process risk and medical device risk.