video1.0<iframe src="https://www.loom.com/embed/7ef2c016bf4b45529fc0c5b5dd3c7e7b" frameborder="0" width="1280" height="960" webkitallowfullscreen mozallowfullscreen allowfullscreen></iframe>9601280Loomhttps://www.loom.com9601280https://cdn.loom.com/sessions/thumbnails/7ef2c016bf4b45529fc0c5b5dd3c7e7b-62b1bf509bcc54f1.gif3407.033333This Loom explains the MDKU organization and the DIN Spec 91509 data model approach for medical device technical documentation. It describes how the model moves from documents to data elements using knowledge topics (central templates) and knowledge units (product-specific realizations), with intended purpose elements consolidated across regulatory sources and published as DIN Spec 91509 release 1 in February 2025. The speakers outline the development process stages, the availability of PDF, XML, and JSON files, and how the model supports traceability and consistency across life cycle documentation to reduce costs and interpretation gaps. They also note that release 2 is targeted for end of year, with release timelines and next KT content under development, and address questions about granularity, tooling needs, expansion plans for cybersecurity groups, and collaboration with eIDIS and DIN IT initiatives.