Health Triage develops medical software based on artificial intelligence, intended for professional use and certified according to the highest European standards. Compliance with international regulations is an integral part of our approach: every technology is designed and developed within a traceable, verifiable, and validated quality system.
Quality Management System Certification – ISO 13485:2016
Health Triage is certified according to ISO 13485:2016, the international standard specific to quality management systems for medical devices.
Certificate no. SCAR – 18.1.1.0 – Scarlet B.V.
Scope: design, development, production, installation, and support of medical software for tumor diagnosis through medical imaging
Issued: 30/04/2026
This company certification ensures that the entire lifecycle of our software is managed according to rigorous, traceable procedures aligned with international regulations on safety and quality.
Product Certification – MDR 2017/745
Health Triage has obtained the European MDR (Medical Device Regulation) certification for BreastNegative, an AI-based mammography diagnostic support software classified as a Class IIb medical device.
Certificate no. SCAR-18.2.1.0 – Scarlet B.V. – Notified Body no. 3022
Valid until 24/07/2030
Why MDR certification matters
Regulation (EU) 2017/745 is the most advanced regulatory framework in Europe for medical devices. BreastNegative has undergone a rigorous assessment process that included:
- clinical risk analysis
- validation of diagnostic performance
- verification of data traceability and security
- lifecycle management of the software in accordance with ISO standards
MDR certification attests not only to the safety and effectiveness of the product, but also to the quality of the entire organization that develops and supports it.