Regulatory news for medical devices and in-vitro diagnostics
All essential changes & really relevant news on regulatory affairs and quality management for medical devices & in-vitro diagnostics: Clearly summarized by our experts and the effects clearly presented for you!
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Presentation materials: Regulatory Update: Sustainability, DiGA, Safety vs. Security, UDI, and EUDAMED from May 21, 2025
in NewsFree basic check ISO 13485: Quality management for medical devices and IVD
in NewsWe are now offering all manufacturers of Class I medical devices a free initial consultation on the introduction of a quality management system in accordance with ISO 13485! In a free 2-hour consultation, our experts will answer your individual questions and show you the best way to meet the legal requirements! Manufacturers of Class I […]
Presentation materials: Regulatory Update: EU AI Act, ISO 13485, ISO 14971, EUDAMED, IEC 62304, DeepTech funding, and MDR best practices from September 22, 2025
in NewsOn September 22, 2025, our regular online forum, Regulatory Update, took place in collaboration with the life science clusters of all Austrian federal states. Around 60 interested parties attended the expert updates and best practice presentations, giving them a quick, up-to-date overview of developments and requirements. We would like to once again express our sincere […]