About VDE
VDE, one of the largest technology organizations in Europe, has been regarded as a synonym for innovation and technological progress for more than 130 years. VDE is the only organization in the world that combines science, standardization, testing, certification, and application consulting under one umbrella. The VDE mark has been synonymous with the highest safety standards and consumer protection for more than 100 years.
Our passion is the advancement of technology, the next generation of engineers and technologists, and lifelong learning and career development “on the job”. Within the VDE network, more than 2,000 employees at over 60 locations worldwide, more than 100,000 honorary experts, and around 1,500 companies are dedicated to ensuring a future worth living: networked, digital, electrical.
Shaping the e-dialistic future.
The VDE (VDE Association for Electrical, Electronic & Information Technologies) is headquartered in Frankfurt am Main. For more information, visit www.vde.com.
VDE Health provides consultation on the regulatory requirements for active medical devices, including medical software. For more information, visit www.vde.com/topics-en/health.
Contribution to ThrombUS+ project: Wearable for continuous monitoring, risk prediction and immediate alert for deep vein thrombosis at the point of care
Within the ThrombUS+ project, VDE plays a central role in ensuring that regulatory, safety, and ethical aspects are systematically integrated into the development of the novel medical device. As leader of Task 2.2, VDE identified and structured all relevant regulatory requirements for the ThrombUS+ system in line with the European Medical Device Regulation (MDR) and the Artificial Intelligence Act as well as other applicable EU cross-sector regulations. VDE addressed key topics such as medical device safety and security as well as trustworthiness of AI systems. To support the consortium, VDE established a comprehensive regulatory knowledge base, developed strategic guidelines and a roadmap for a “compliance-by-design” approach, and organized targeted training activities to raise awareness and build regulatory expertise across partners.
Building on this foundation, VDE also leads Task 9.1, which focuses on the continuous monitoring and implementation of regulatory compliance throughout the project lifecycle. Here, VDE translates the compliance-by-design concept into practice by providing extensive support for the creation of technical documentation, including templates and hands-on guidance, and ensuring that regulatory requirements are embedded early in research and development activities. Through training workshops, technical reviews, and close collaboration with partners, VDE facilitates the integration of safety, performance, and quality requirements – such as AI trustworthiness, medical device development and production, risk management, clinical evaluation and investigation, and software lifecycle processes – into the overall system design. This proactive and structured approach ensures that regulatory compliance is continuously monitored, mitigated, and aligned with project progress, ultimately enabling a smoother transition from innovation to clinical application.
