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 worlds 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 Eu...