Upcoming regulations in the medical devices industry (MDR, IDR) push for traceability of products and product-related data beyond the production and supply chain scenarios, demanding a real end-to-end traceability for the entire life cycle of a product. The big challenge in the EU is providing information on product safety and use on the market.
The technologies to do end-to-end product traceability for all stakeholders along a product’s life cycle is there. The challenge is to integrate these into existing infrastructure and be ready for operation even though EUDAMED is still being specified. However, real-world requirements go far beyond pushing data to EUDAMED. We help you navigate these challenges.
System Development Services
We bring expertise in the challenges of all aspects: medical device development, the understanding of the new regulations, expertise in developing traceability systems, and an understanding of the respective data integration problems. We help you to realise your integration to EUDAMED with the supporting IT infrastructure and software.
Supporting Technology Solutions
In order to illustrate the use case of traceability over the entire product life cycle, we developed technology demonstrators showcasing track & trace for medical devices, currently interacting with an FDA database. We also provide a Blockchain based solution that illustrates trusted product traceability.