Medical Device Knowledge Units (MDKU) e.V.

We are a German based non-profit association founded by stakeholders from the European medical technology sector that are working together on the world's first unique free of charge regulatory data model for the technical documentation for medical devices. Our motivation: We want to accelerate digitalization in the industry in order to increase efficiency in product development and achieve shorter market approval procedures - and thereby enable more innovations for diagnosis and therapy of patients. Why a non-profit organisation? Our industry is diverse and the regulatory landscape complex and volatile. A regulatory data model can only be developed quickly if we use the powerful knowledge and experience from our community. We want to ensure that all parties in the industry ecosystem benefit quickly from digitalization - regardless of whether they are global players, start-ups, notified bodies or other regulatory authorities. We focus on the development of a data model for the European market and compliance with the MDR/IVDR in close cooperation with regulatory parties. In order to do so, we have set up expert groups for different topics, incl. technical documentation, product development, risk management, usability engineering, clinical evaluation, PMCF, PMS etc. Interested? Stay tuned & follow our LinkedIn profile! - We are working on a new website - We will use LinkedIn for collection of feedback regarding discussions in the expert groups - We will publish results on LinkedIn to ensure transparency Want to join the MDKU? Get in contact with us! Let's revolutionize regulatory affairs and the way of documentation! Details: > DE, Hintergrund: https://www.youtube.com/watch?v=xbIV__VrvaQ&list=PLZT4OFapWENdZCgNthg3cgShvRaKpflq4 > DE, Ziele: https://www.youtube.com/watch?v=gaGNUsKiwwY&list=PLZT4OFapWENdZCgNthg3cgShvRaKpflq4&index=2 > EN, Presentation (from min. 17): https://www.youtube.com/watch?v=gGM-KKlIE