The U.S. Food and Drug Administration (FDA) has issued a comprehensive guidance titled “Computer Software Assurance for Production and Quality System Software“ on 23rd September 2025, which presents nonbinding recommendations for validating computers and automated data processing systems used in medical device production or within the quality system. Prepared by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER), this document establishes a risk-based framework for Computer Software Assurance (CSA)—that specifically integrates modern concepts, including cybersecurity requirements, directly into quality assurance activities. Detailed articles can be found here https://aktriva.com/articles/cybersecurity-in-quality-fdas-guidance-on-computer-software-assurance/