Aura Health is a SaMD and AI medical device consultancy for clinical apps, AI medical devices, healthtech wearables, VR and XR therapeutics, and software IVDs. Our experts guide software and AI medical device companies from the initial idea to a commercially viable and clinically proven product, covering every step, from ISO 13485 QMS development and regulatory strategy to clinical evaluation, IP, health economics, and market access. With offices in Copenhagen, Zagreb, Berlin, and Zürich, we build partnerships with the global startup ecosystem and medical device leaders in the life sciences industry through a practical and problem-solving approach. Our work focuses on creating safe, effective, and patient-centered digital health technologies that make care more accessible. Our R&I teams collaborate with startups, hospitals, and research organizations in the full development and validation process of medical software and connected devices. We believe responsible technology in healthcare starts with trust and that every product we help shape should be transparent, reliable, and built around real patient needs. Our expertise covers integrated digital products and beyond-the-pill solutions, precision and personalized medicine, diagnostics, digital health, and therapeutic software. We have an international team of talent that lives by the values of exceptional design, globally leading innovation, and a workplace culture that supports employees in their professional and personal lives.

Aura Health

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