Benefits of the Data Model
The MDKU data model will be published free of charge in order to support the industry.
Through the unambiguous description of regulatory terms, intended for creation of clarity as to what is understood by a term or is expected by notified bodies. Today, terms are sometimes defined differently in several regulatory documents, interpreted incorrectly, or used in slightly different ways.
through a uniform data model that can be used by all stakeholders in the MedTech ecosystem and implemented by all software providers. This also enables consistency and a digital thread between manufacturers, notified bodies, suppliers and other parties.
Goals: efficient creation, review and management of TD
With the unified data model, we can achieve many benefits for manufacturers as well as for Notified Bodies.