22.08.2025

Altris AI Achieves MDSAP Certification, Strengthening Global Presence and Clinical Credibility

Altris Inc., a leading AI decision support platform for OCT scan analysis, proudly announces that it has passed the Medical Device Single Audit Program (MDSAP) audit. 

Based on the objective evidence reviewed, this audit enables a recommendation for Initial certification to ISO 13485:2016 MDSAP, including the requirements of Australia, Brazil, Canada, the USA, and Japan, and EU 2017/745, and that the scope was reviewed and found to be appropriate for ISO 13485:2016/MDSAP and EU MDR 2017/745.

The results of this audit are suitable for obtaining the EU MDR 2017/745 certificate, which we are currently in the process of pursuing.

ISO 13485:2016/MDSAP enables Altris Inc. to “design, manufacture, and distribute medical software for the analysis and diagnosis of retinal conditions globally.” It is recognized by leading global health regulators and signals trust and credibility to public and private hospitals, eye care networks, and optometry chains worldwide. 

MDSAP Certification also opens the door for Altris Inc. to enter new international markets, including Asia-Pacific, Latin America, and additional parts of North America. The MDSAP certification allows a single regulatory audit of Altris AI’s Quality Management System (QMS) to be recognized by multiple major health authorities, including:

• FDA (United States)
• Health Canada
• TGA (Australia)
• ANVISA (Brazil)
• MHLW/PMDA (Japan)

MDSAP enforces that the Quality Management System for developing, testing, and maintaining AI Decision Support for OCT complies with international medical device standards. Altris AI Decision Support for OCT Analysis system that facilitates the detection and monitoring of over 70 retinal pathologies and biomarkers, including early signs of glaucoma, diabetic retinopathy, and age-related macular degeneration. 

“Achieving ISO 13485:2016 certification under the stringent MDSAP requirements is a significant accomplishment for our team,” said Maria Znamenska, MD, PhD, Chief Medical Officer at Altris AI. “As a practicing ophthalmologist, I understand that the safety of patients is the absolute priority. Especially when implementing such an innovative technology as AI for decision support in OCT analysis. That is why we did everything possible to build quality processes that guarantee the highest level of safety for the patients.

This certification enables Altris AI to expand its presence and offer eye care specialists upgraded functions such as GA progression monitoring, flags for smart patient filtering, or automated drusen count.”

“This is more than a regulatory milestone for our team  – it’s a signal to the global eye care community that Altris AI is a trusted clinical partner,” said Andrey Kuropyatnyk, CEO of Altris AI. 

About Altris AI

Founded in 2017, Altris AI is at the forefront of integrating artificial intelligence analysis into ophthalmology and optometry.

The company’s platform is designed to assist eye care professionals in interpreting OCT scans with greater objectivity and make informed treatment decisions. It’s a vendor-neutral platform compatible with OCT devices from 8 major global manufacturers. With a commitment to innovation and compliance, Altris AI continues to develop solutions that set higher standards in the eye care industry and improve patient outcomes.