Tag Archives: Quality Systems

Embracing the Shift: FDA’s New Risk-Based Approach to Non-Device Software Assurance in Medical Device Industry

The Food and Drug Administration (FDA) has recently released a draft guidance that signals a significant shift in their approach to software used in the production and quality systems of medical devices. This new guidance, titled “Computer Software Assurance for Production and Quality System Software”, emphasizes a risk-based, lifecycle approach to software assurance, moving awayContinue reading “Embracing the Shift: FDA’s New Risk-Based Approach to Non-Device Software Assurance in Medical Device Industry”