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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…
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The Cybersecurity and Infrastructure Security Agency (CISA) is requesting public comment on its 2025 Minimum Elements for a Software Bill of Materials (SBOM) draft update, which aims to reflect the current maturity in software transparency and supply chain security. This update builds upon the 2021 NTIA SBOM Minimum Elements to help agencies and organizations more effectively manage software…
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Microsoft will officially end updates and security support for Windows 10 on October 14, 2025 completing a 10 year long run. After this date, standard editions of Windows 10 will no longer receive security patches, bug fixes, or technical support. While devices running Windows 10 will continue to function, the lack of updates raises significant cybersecurity and regulatory…
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This post describes key requirements for medical device manufacturers to follow when submitting their devices to US FDA for PMA or 510K approvals. The United States Food and Drug Administration (FDA) provides guidance on cybersecurity in medical devices, outlining both recommended activities and documentation for premarket submissions like 510(k)s and Premarket Approval Applications (PMAs). For a specific…
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The guidance document titled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,” released on June 27, 2025, replaces the previous guidance issued on September 27, 2023. This updated version integrates content from the draft select update published on March 13, 2024, along with additional new material not included in the draft.…