The provider of AI-enabled medical imaging software is now certified under ISO/IEC 42001:2023 for responsible AI management.
Subtle Medical, a provider of artificial intelligence (AI)-powered medical imaging software, has earned one of the first accredited ISO/IEC 42001:2023 certifications for its AI Management System.Â
ISO/IEC 42001 is the world’s first international standard specifically focused on the management of AI. 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,” says Ajit Shankaranarayanan, PhD, chief product officer, in a release. “This certification provides independent validation of our AI development processes and confirms we are ahead of the curve.”
Ben Wright, head of IT and cybersecurity, says that customers are increasingly asking vendors to prove how they govern AI. “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,” he says in a release.
Subtle Medical’s path to certification accelerated when it was selected by Intertek, a 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 US Food and Drug Administration guidance and rigorous quality standards, according to a release from the company.
“Between every FDA submission, we refine our processes to reflect the latest regulatory expectations,” says Ronny Elor, head of quality engineering and regulatory affairs, in a release. “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.”
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