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 /PRNewswire/ -- 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.

"As the regulatory landscape evolves rapidly in response to AI innovation, Subtle Medical remains committed to the highest standards in patient safety and product quality," said Ajit Shankaranarayanan, PhD, Chief Product Officer. "This certification provides independent validation of our AI development processes and confirms we are ahead of the curve."

The certification has already proven relevant to Subtle Medical's commercial operations.

"Customers are increasingly asking vendors to prove how they govern AI," said Ben Wright, Head of IT and Cybersecurity. "We've seen AI-related questions added to supplier evaluations, and I've personally engaged with AI governance boards at several customer organizations. This certification confirms we're aligned with the best practices."

Benefits of ISO/IEC 42001 Certification Include:

• Patient Safety: Ensures Subtle Medical's management system supports a fair, secure and clinically robust AI life cycle.
• Customer Confidence: Demonstrates that Subtle's AI governance meets global standards.
• Risk Mitigation: Prioritizes proactive risk management across AI development and deployment.
• Operational Excellence: Integrates quality practices across the product lifecycle for continuous improvement.

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.

"Between every FDA submission, we refine our processes to reflect the latest regulatory expectations," said Ronny Elor, Head of Quality Engineering and Regulatory Affairs. "By the time we began ISO 42001 preparations, we found that much of our system already met the criteria. It was rewarding to formalize what we've already built."

Looking ahead, the certification will support Subtle Medical's continued growth and innovation. Visit their Compliance page for more information or book a demo to learn more about AI software solutions for faster and higher quality medical imaging.

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
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SOURCE Subtle Medical, Inc.