Zdrowie i gospodarka · 13/09/2022

FDA Releases Draft Guidance on Computer Software Assurance for Medical Devices

The Food and Drug Administration (FDA) has released a draft guidance titled "Computer Software Assurance for Production and Quality System Software," which provides recommendations for ensuring the reliability of computer software in medical device production and quality systems. The draft guidance aims to promote compliance with FDA regulations while facilitating the adoption of innovative technologies in the medical device industry.