SmartCyber

SmartCyber’s goal is to establish a secure and transparent product lifecycle for connected medical devices, covering everything from development and approval to clinical use. In an increasingly digitized healthcare system, it is crucial that medical devices function correctly and are protected against cyberattacks and tampering. SmartCyber’s goal is to establish an integrated, modular framework that will enable all stakeholders, including manufacturers, users, notified bodies and regulatory authorities, to systematically identify, assess, document and manage cyber security risks. The framework considers both regulatory requirements and practical feasibility. The aim is to establish transparent, automated, and sustainable security processes, thereby paving the way for trustworthy digital medical technology in the future.