Sensor- and app-based validation of process and product quality for effort-reduced certification of personalized medical devices

Personalized medical devices are subject to strict safety requirements. Thus, the influence of a large number of parameters in the additive manufacturing of individualized medical components must be validated. The resulting complex approval procedures present SMEs with major methodological and economic challenges.

The research project SAViour is concerned with the development of a quality management system for real-time monitoring of process parameters in additive manufacturing. Product quality is monitored using a quality model based on the machine learning process. The data required for this is collected using a sensor concept developed in-house, which is integrated directly into the 3D printing process. The data obtained can additionally be used for holistic process optimization. The process is implemented and researched using Fused Deposition Modeling (FDM).

The goal is to create an app that enables process correction and documents the quality of the manufactured components and the process.