1. Documentation Level: End of Level of Concern On June 14, 2023, the FDA released the guidance document Content of Premarket Submissions for Device Software Functions. This document replaces the guidance document introducing the Level of Concern and only distinguishes between two classes. a) Determination of the classes The FDA no longer defines three “Level…
DetailsSoftware maintenance is the phase in which software is further developed, e.g., with the objective of According to the FDA, 79% of all bugs occur during software maintenance. Accordingly, some regulations address this topic. Regulatory requirements for software maintenance Requirements of the Medical Device Regulation MDR (2017/745) The Medical Device Regulation requires medical device manufacturers…
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