EN ISO 13485 Certified

Origin Health is certified (TUV Rheinland ID 9000017749) for EN ISO 13485, an international standard for Quality Management System (QMS) of medical device companies.

The EN ISO 13485 is an internationally recognized standard for the medical device industry for implementing and maintaining a robust quality management system (QMS). The EN ISO 13485 certification has been issued after rigorous on-site audits to verify the capability and reliability of our QMS by experts on its practical application and degree of effectiveness in the areas of design, development of Lucina (Software as a Medical Device).

The certification allows Origin Health for the design and development, manufacture, and distribution of artificial intelligence (AI) based medical image processing software for the assessment of fetal ultrasound scans.