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USFDA Medical Devices Guidance: Computer Software Assurance for Production, Quality Management System Software & Cybersecurity, QMS Considerations and Content of Premarket Submissions
In February 2026, FDA issued an updated guidance titled Computer Software Assurance for Production and Quality Management System Software , superseding the September 2025 version. In parallel, FDA released an updated Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions guidance, reflecting the growing cyber risk associated with digital and connected medical technologies. Together, these guidances signal a shift awa
Sharan Murugan
21 hours ago3 min read