More and more medical devices are using artificial intelligence to diagnose patients more precisely and to treat them more effectively. Although a lot of devices have already been approved (e.g., by the FDA), a lot of regulatory questions remain unanswered. With the AI Act, the EU has published a regulatory framework for AI, and not…
DetailsLaws and standards require medical device manufacturers to compile a Software Bill of Materials, the SBOM. However, standardized SBOM formats are not always sufficient to meet these requirements. In particular, medical device manufacturers who do not supply and use SBOMs for their software are no longer accepted in the market. Here are the reasons. 1.…
DetailsThe Medical Device Regulation (MDR) (like the Medical Device Directive (MDD) and thus the Medical Device Act before it) requires manufacturers to comply with life cycle processes for their software. IEC 62304 and IEC 82304 also refer to software life cycle processes. But what is a software life cycle? The software life cycle includes all…
Details1. 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. Update: Addition to software maintenance during development Regulatory requirements for software maintenance Requirements of the Medical Device Regulation MDR (2017/745) The…
DetailsGLP (Good Laboratory Practice) defines requirements for a quality assurance system for non-clinical health and environmental safety tests. It also describes the organizational procedure and conditions under which laboratory tests are planned, carried out, and monitored. GLP also covers the record and reporting of. In this article, you can read which requirements medical device manufacturers…
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