Aura Health

Aura Health is a consultancy specializing in Software as a Medical Device (SaMD) and AI for clinical applications, AI medical devices, health technology wearables, virtual and augmented reality therapeutics, and software-based in vitro diagnostics. Our team assists companies in the software and AI medical device sectors from the conception of their ideas to the delivery of clinically validated, commercially successful products. We address all aspects of the development process, including ISO 13485 Quality Management System development, regulatory strategy, clinical evaluation, intellectual property, health economics, and market access. With locations in Copenhagen, Zagreb, Berlin, and Zürich, we foster collaborations with the global startup ecosystem and leading medical device companies within the life sciences sector, taking a practical problem-solving approach. Our focus is on developing safe, effective, and patient-centered digital health technologies that enhance access to care. Our Research and Innovation teams work closely with startups, hospitals, and research institutions throughout the complete development and validation of medical software and connected devices. We believe that responsible healthcare technology must be rooted in trust, and we strive to ensure that every product we assist in creating is transparent, trustworthy, and centered around actual patient needs. Our expertise extends to integrated digital products, beyond-the-pill solutions, precision and personalized medicine, diagnostics, digital health, and therapeutic software. We pride ourselves on having an international team committed to exceptional design, leading global innovation, and a workplace culture that nurtures employees both professionally and personally.