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Subtle Medical's ISO/IEC 42001:2023 Certification: A Milestone in AI Management

Subtle Medical has made a significant stride in the field of artificial intelligence (AI) in medical imaging by becoming one of the first organizations to achieve the ISO/IEC 42001:2023 certification. Announced on July 30, 2025, this recognition underscores the company's commitment to the ethical and effective use of AI technologies in healthcare.

What is ISO/IEC 42001:2023?

ISO/IEC 42001:2023 is the world's first international standard that specifically addresses the management of artificial intelligence systems. It sets a benchmark by outlining the requirements for organizations to manage AI responsibly, ensuring that AI systems are transparent, fair, robust, and secure. By attaining this certification, Subtle Medical has demonstrated that it utilizes a rigorous and auditable system for overseeing the ethical application of its AI solutions.

Commitment to Safety and Quality

At the heart of this achievement is Subtle Medical's dedication to patient safety and product quality. Dr. Ajit Shankaranarayanan, Chief Product Officer, emphasized that as the landscape of AI regulations continues to develop, the company remains steadfast in adhering to the highest safety standards. He noted, "This certification provides independent validation of our AI development processes and confirms we are ahead of the curve."

Moreover, the ISO certification is vital for Subtle Medical's commercial engagements. As Ben Wright, the Head of IT and Cybersecurity, pointed out, there is an increasing demand from vendors to demonstrate effective governance concerning AI technologies. Consequently, this certification serves to solidify Subtle Medical's reputation as a leader aligned with best practices in AI governance.

Benefits of Achieving ISO/IEC 42001 Certification

The certification opens several doors for Subtle Medical, offering a multitude of benefits such as:

• - Enhanced Patient Safety: It ensures that the company's management framework supports a clinically robust AI life cycle.
• - Increased Customer Confidence: This accreditation conveys that Subtle Medical's AI governance is on par with global standards.
• - Proactive Risk Mitigation: The certification promotes a preventive approach to risks associated with AI development and deployment.
• - Operational Excellence: The framework integrates quality protocols throughout the product life cycle, facilitating continuous improvements in processes.

Pathway to Certification

Subtle Medical’s journey to secure ISO/IEC 42001 certification was significantly bolstered by its selection for an accreditation witness audit from Intertek, a prominent provider of Total Quality Assurance services. The preparatory work undertaken by Subtle Medical over years of close alignment with the evolving FDA regulations and stringent quality standards was instrumental in achieving this milestone.

Ronny Elor, Head of Quality Engineering and Regulatory Affairs, stated, "Between every FDA submission, we refine our processes to reflect the latest regulatory expectations." He further added that by the time the organization initiated its ISO 42001 preparations, much of their existing framework was already compliant with the standards, making their efforts to formalize their practices particularly gratifying.

The Future of Subtle Medical

Looking ahead, the ISO/IEC 42001 certification is poised to bolster Subtle Medical's ongoing growth and innovation in the medical imaging sector. The company continues to emphasize the importance of this certification on its website, inviting users to explore their compliance efforts or book a demo to experience their advanced AI solutions firsthand.

Subtle Medical, recognized as a pioneering provider of AI-driven imaging solutions, is committed to enhancing the efficiency and quality of medical imaging scans. Their technology has already been deployed across over 900 scanners worldwide, significantly improving workflow efficiency in radiology facilities and enhancing patient care quality.

Conclusion

Subtle Medical’s ISO/IEC 42001:2023 certification highlights not just a significant achievement for the company, but also serves as a model for other organizations in the healthcare technology space. As AI continues to evolve within the medical field, Subtle Medical stands as a vanguard, setting standards that other companies may aspire to achieve.