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ST: Fachverband Strahlen- und Medizinphysik

ST 4: DPG meets DGMP: Von der Idee bis zur klinischen Anwendung

ST 4.2: Hauptvortrag

Mittwoch, 22. März 2023, 14:20–14:40, ZEU/0146

Development and Certification of an IGRT system — •Claus Promberger — Brainlab AG, München

As a mid-size company we decided several years ago to redesign a successful IGRT product line to follow current and upcoming regulations and standards in development, verification, validation and certification processes. The journey will be presented which ends again in a successful product and even in a nomination for the "Deutsche Zukunftspreis". The focus will be on the necessary tasks and timeline to bring a fully MDR certified product consisting of software and hardware components to the market in the EU and to keep it there.