Tag Archives: IEC 62304

Revolutionizing Medical Device Software: A Look at the New FDA Guidance

On June 14, 2023 the U.S. Food and Drug Administration (FDA) finalized a new guidance document (Content of Premarket Submissions for Device Software Functions) that could be the shift in policy that marks a significant step towards modernizing and streamlining the regulatory process for medical device software, potentially leading to faster innovation and improved patientContinue reading “Revolutionizing Medical Device Software: A Look at the New FDA Guidance”