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Zdrowie i gospodarka · 24/09/2025

FDA Announces Final Guidance on Computer Software Assurance for Medical Devices

The Food and Drug Administration (FDA) has released a final guidance document titled 'Computer Software Assurance for Production and Quality System Software' to provide recommendations on ensuring the quality and security of computer software used in medical device production and quality systems.

Source: Federal Register — Food and Drug AdministrationOpen original release →