About the MDKU
We are a nonprofit organization founded in 2021 by a community of people from the medtech industry in order to achieve the previously listed goals based on a unified data model for the content of technical documentation of medical devices.
Our members are experts from medical device manufacturers, consultancy companies, service providers, software providers and other organizations with which we cooperate and collaborate. All of them are dealing with the challenges of medical device processes and documentation every day.
We screen regulatory documents and extract terms („Knowledge Topics“) that represent particular content that is expected in the technical documentation. We develop clear descriptions for each of those Knowledge Topics and provide additional information, how the term is used and on which regulatory basis the description was developed. Furthermore, we provide the visualisation of a hierachy of terms, helping users to understand the context of a single term.
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The MDKU data model will be published free of charge in order to support the industry. We have no commercial interests. On the contrary, we have committed ourselves to support our MedTech community and eliminate time wasting activities from our own daily lives – for the benefit of better patient care.
Who has commissioned us?
We – the experts in our industry – are convinced that we have to change the way how we created and maintain information related to medical devices. And the basis for a more efficient information management and digitalization is standardization of the language that we use every day in the documentation.
In 2019, none of the existing regulatory organizations were working on a such an concept and therefore we decided: We, the MedTech community, have to develop such a data model by ourselves. From the community, for the community. And the idea of a MDKU was developed.
We are not commissioned by any national authority, notified body, industry association or company. But we are supported by many stakeholder in the ecosystem that share our vision: a simplified regulatory framework through a clear language of used terms.
It is important for us that no commercial interests are pursued and that the data model is made available as easy as possible for all stakeholders in the industry in order to ensure broad application. In other words, no software will be developed for the application of the MDKU data model, but it will be ensured that the data model can be used by all common software solutions for the digitization of regulatory processes.
MDKU Medical Device Knowledge Units e.V.
Am Weichselgarten 7
91058 Erlangen
Germany