MDKU
Home Status quo Challenges Digitalization Benefits About MDKU Who we are Independency Working Groups Data Model Elements Definition Hierarchy Content Licence Feedback Participate Our Statute Contact My MDKU Home Status quo Challenges Digitalization Benefits About MDKU Who we are Independency Working Groups Data Model Elements Definition Hierarchy Content Licence Feedback Participate Our Statute Contact My MDKU Let’s imagine, in our regulated MedTech industry we … have a clear regulatory language that enables easier interpretation of regulatory terms in regulatory documents can easily digitalize regulatory processes in order to speed up creation and review of the technical documentation can increase efficiency of medical device development, market access and thus reduce costs in the overall medtech ecosystem enable more and faster innovation and thus better patient care … and ensure that the European MedTech industry is well positioned for the age of digitalization and global competition. Our Mission We are a nonprofit organization with stakeholders from the MedTech industry and convinced, that an open source data model for content of the technical documentation for medical devices can accelerate digitalization and innovation in our industry. Due to the high complexity of content and variety of involved disciplines, such a data model can only be developed by the MedTech community for the MedTech community: That is what we do. Our goals: A clear regulatory language and foundation for an efficient digitalization – for medical device manufacturers, notified bodies and other stakeholders. This is our contribution to better patient care in Europe. Status quo The pace of innovation in Europe has slowed massively. New medical devices are approved more quickly in the USA and other countries. Read more Challenges Creation and ongoing maintenance of technical documentation files in the post-market phase are complex and time consuming. Read more Digitalization Digitalized regulatory lifecycle processes, technical documentation and submission procedures can immensely increase efficiency. Read more Benefits A unified data model supports the standardization of processes, content, data exchange and is the foundation for digitalization. Read more MDKU Medical Device Knowledge Units e.V. Am Weichselgarten 7 91058 Erlangen Germany My MDKU Contact Imprint Privacy Policy Cookie guideline (EU)
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https://mdku.digital/https://mcp.mdku.digital/mcpThis server may ask you to sign in when your AI client connects.
Last probed Nov 3, 2026 · mcp.mdku.digital
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Directory coverage for brandsHome Status quo Challenges Digitalization Benefits About MDKU Who we are Independency Working Groups Data Model Elements Definition Hierarchy Content Licence Feedback Participate Our Statute Contact My MDKU Home Status quo Challenges Digitalization Benefits About MDKU Who we are Independency Working Groups Data Model Elements Definition Hierarchy Content Licence Feedback Participate Our Statute Contact My MDKU Let’s imagine, in our regulated MedTech industry we … have a clear regulatory language that enables easier interpretation of regulatory terms in regulatory documents can easily digitalize regulatory processes in order to speed up creation and review of the technical documentation can increase efficiency of medical device development, market access and thus reduce costs in the overall medtech ecosystem enable more and faster innovation and thus better patient care … and ensure that the European MedTech industry is well positioned for the age of digitalization and global competition. Our Mission We are a nonprofit organization with stakeholders from the MedTech industry and convinced, that an open source data model for content of the technical documentation for medical devices can accelerate digitalization and innovation in our industry. Due to the high complexity of content and variety of involved disciplines, such a data model can only be developed by the MedTech community for the MedTech community: That is what we do. Our goals: A clear regulatory language and foundation for an efficient digitalization – for medical device manufacturers, notified bodies and other stakeholders. This is our contribution to better patient care in Europe. Status quo The pace of innovation in Europe has slowed massively. New medical devices are approved more quickly in the USA and other countries. Read more Challenges Creation and ongoing maintenance of technical documentation files in the post-market phase are complex and time consuming. Read more Digitalization Digitalized regulatory lifecycle processes, technical documentation and submission procedures can immensely increase efficiency. Read more Benefits A unified data model supports the standardization of processes, content, data exchange and is the foundation for digitalization. Read more MDKU Medical Device Knowledge Units e.V. Am Weichselgarten 7 91058 Erlangen Germany My MDKU Contact Imprint Privacy Policy Cookie guideline (EU)
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