Overview:
Aura Health is a digital health company that improves the quality of life for patients with chronic diseases by delivering high-quality software and medical technology solutions. We act as a critical supplier/subcontractor on projects developing software as a medical device (SaMD) and digital therapeutics (DTx) products under an ISO 13485 QMS-certified by BSI Notified Body.
Our company is listed in the Eudamed database under Actor ID/SRN HR-MF-000044251. We have an in-house process, and our expert teams handle every aspect of medical device business strategy, product development, quality assurance, medical affairs, and regulatory compliance.