Subtle Medical Among First to Achieve ISO/IEC 42001:2023 Certification for AI Management
The certification reinforces the company’s leadership in AI safety, efficacy, and ethical governance.
MENLO PARK, Calif. – July 30, 2025 – Subtle Medical, a global leader in AI-powered medical imaging software, announced it has earned one of the first accredited ISO/IEC 42001:2023 certifications for its AI Management System. This milestone reflects Subtle Medical’s leadership in developing safe, effective, and ethically governed AI solutions in medical imaging.
ISO/IEC 42001 is the world’s first international standard specifically focused on the management of artificial intelligence. Achieving this certification signals that Subtle Medical has implemented a robust and auditable system for overseeing the responsible use of AI—addressing key requirements around transparency, fairness, explainability, robustness, and security.
The certification has already proven relevant to Subtle Medical’s commercial operations.
Benefits of ISO/IEC 42001 Certification Include:
Subtle Medical’s path to certification accelerated when it was selected by Intertek, a leading Total Quality Assurance provider to industries worldwide, for its accreditation witness audit. The company’s readiness was the result of years of internal alignment with evolving FDA guidance and rigorous quality standards.
About Subtle Medical
Subtle Medical is a leading provider of AI-powered imaging solutions, optimizing scan efficiency and image quality across radiology. Recognized as a CB Insights GenAI 50 company and a two-time CB Insights Top AI 100 and Digital Health 150 company, Subtle Medical is committed to driving innovation in medical imaging. Deployed globally across 900+ scanners worldwide, Subtle Medical’s solutions help imaging centers and hospitals improve workflow efficiency, increase scanner sustainability, and elevate patient care. Learn more and request a demo at www.subtlemedical.com.
Media Contact:
Anna Menyhart-Borroni
Head of Global Marketing
anna@subtlemedical.com