RAPS Euro Convergence is the most comprehensive regulatory affairs conference in Europe, focusing on the latest topics and developments in healthcare products in Europe and beyond — with sessions in medical devices, IVDs, pharmaceuticals, combination products, regulatory business, AI, software, and cybersecurity. On May 15 from 14:30 to 15:30, Sarah Panten, together with Daniel Prell and Said Frédéric from Siemens Healthineers, will present on "Benefits of Standardized Data Models for Digitalization in the Medtech Industry", exploring how standardized data models drive efficiency and innovation in the industry.

Benefits of standardized data models for digitalization in the Medtech industry

In order to remain competitive in the long term, more and more medtech companies have begun to digitalize their product life cycle processes and the associated technical documentation (TD). For such digitalization projects, data models are the foundation for the clear identification and consistent reuse of information across different elements of the TD. Until now, there is no uniform data model in the Medtech industry. That means each company must develop the appropriate data model for itself and its portfolio. This involves the risk of individual interpretations when implementing regulatory requirements in a data model, and ultimately there is the question of acceptance by the notified body. Harmonized data models offer many advantages: 

1. Costs for individual development in companies are reduced.
2. A standard regulatory language is established, leading to more clarity in the industry and higher acceptance by notified bodies.
3. Digitalization in medtech is massively accelerated, which ultimately leads to more innovation and better patient care.

In this session, the concept of a unified data model will be explained for the example ”Intended Purpose”, which was developed in form of a pilot project for Europe in 2024. It is explained, how the data model was developed, what the challenges were and how the data model is now being iteratively extended. Furthermore, the benefits of a unified data model are explained from the perspective of a global medtech company and how such data models are intended to be used in the future.