The implementation of IEC 62366-1 usability engineering is essential for developing Software as a Medical Device (SaMD) and Digital Therapeutics (DTx). Systematic application of usability engineering principles enables these digital health products to fulfill stringent regulatory standards, significantly enhance patient safety, boost user engagement, and optimize therapeutic outcomes. A structured IEC 62366-1 approach ensures that […]
At Aura Health, extensive experience in medical device design and development has highlighted one key principle: research-driven medical device innovation is the foundation of effective product development. Our expertise lies not only in mastering medical concepts but also in bridging the gap between theoretical frameworks and practical, real-world user needs. Our integrated team of User […]
Aura Health is a SaMD and DTx digital-health software-engineering partner that architects, codes, and validates solutions on top of the leading commercial platforms, or cloud stacks our clients already own. Our role is to give life-science organisations the shortest, safest route from clinical concept to globally deployable SaMD product. Randomized trials and real-world data now […]
Date: 5 June 2025 Time: 10:00h Venue: University of Zagreb / Sveučilište u Zagrebu, Radoslava Cimermmana 88 (Hall B1) 1. What is Morning Health Talks? Morning Health Talks is the Croatian EIT Health Hub’s breakfast-style meet-up where clinicians, researchers, entrepreneurs, and policy-makers swap insights on the most pressing issues in health innovation. Each edition spotlights […]
The age of insight, not just instrumentation The differentiator in 2025 is a deliberate medtech data strategy. Connected sensors, SaMD companions, and cloud dashboards now sit at the heart of virtually every new medical-technology product. Each heartbeat captured by an implantable monitor, every glucose curve streamed from a wearable CGM, carries a double payload: clinical […]
In the evolving ecosystem of life sciences and healthcare delivery, digital health has emerged not only as a technological adjunct but as a core strategic pillar in drug commercialization and lifecycle management. For pharmaceutical manufacturers, the integration of digital health solutions is no longer a novelty or a differentiator. It is a requirement for delivering […]
Transferring your Swiss Authorized Representative (CH-REP) is a critical regulatory activity requiring meticulous planning, rigorous execution, and thorough knowledge of regulatory requirements. As Switzerland’s regulatory landscape closely mirrors the EU’s stringent standards, understanding these requirements in detail is vital for a successful transition. This blog post delves deeply into each step necessary for smoothly transferring […]
In October 2024, Tsinghua University’s Institute for Artificial Intelligence Industry Research in Shijiazhuang, Hebei Province, unveiled Agent AI Hospital, the first fully autonomous healthcare facility managed by AI agents. This virtual hospital deploys fourteen physician agents and four nursing agents to handle every step of patient care—triage, diagnostic testing, treatment planning, and follow-up—within simulated consultation […]
Introduction to healthcare AI lifecycle Artificial Intelligence (AI) is transforming healthcare at an unprecedented pace. From predictive analytics that forecast hospital readmissions to deep‑learning algorithms that detect abnormalities in radiology images, AI promises more accurate diagnoses, personalized treatments, and streamlined operations. Turning a healthcare AI concept into a reliable clinical asset requires a structured, repeatable […]
Aging, an inevitable biological process, has long been associated with a decline in physiological functions and an increased risk of chronic diseases. However, recent advancements in aging research and drug discovery are challenging this narrative, offering promising avenues to not only extend lifespan but, more importantly, healthspan—the period of life spent in good health. This […]
