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.

MDKU Medical Device Knowledge Units e.V. 

Am Weichselgarten 7

91058 Erlangen