Subtle Medical Achieves One of the First ISO/IEC 42001:2023 Certifications for AI Management
Subtle Medical, a leader in AI-powered medical imaging software, has earned one of the earliest accredited ISO/IEC 42001:2023 certifications for its AI Management System. This international standard is the first to focus specifically on managing artificial intelligence, setting clear expectations for safety, transparency, fairness, and security in AI applications.
By achieving this certification, Subtle Medical demonstrates that it has implemented a comprehensive and auditable system that governs AI responsibly throughout its lifecycle. This includes ensuring explainability, robustness, and ethical oversight, which are critical in medical imaging technologies.
Commitment to Patient Safety and Quality
“As regulatory requirements evolve alongside AI advancements, maintaining high standards in patient safety and product quality is essential,” said Ajit Shankaranarayanan, PhD, Chief Product Officer at Subtle Medical. The certification acts as independent verification that the company’s AI development processes are ahead of current expectations.
Ben Wright, Head of IT and Cybersecurity, adds that the certification also supports customer demands. “More healthcare providers now require proof of AI governance during supplier evaluations. This certification confirms we follow best practices, which strengthens trust with our clients.”
Key Benefits of ISO/IEC 42001 Certification
- Patient Safety: Ensures AI systems are fair, secure, and clinically reliable throughout their lifecycle.
- Customer Confidence: Demonstrates compliance with internationally recognized AI governance standards.
- Risk Management: Supports proactive identification and mitigation of risks during AI development and deployment.
- Operational Excellence: Embeds quality controls and continuous improvement across product processes.
Path to Certification
Subtle Medical's journey to certification was supported by Intertek, a global Total Quality Assurance provider, which conducted the accreditation witness audit. The company's internal processes already aligned closely with FDA guidance and quality standards, making the certification a formal recognition of existing practices.
Ronny Elor, Head of Quality Engineering and Regulatory Affairs, explained, “Each FDA submission refines our processes to meet updated regulatory expectations. When preparing for ISO 42001, much of our system already complied with the criteria, so certification formalized what was already in place.”
Looking Ahead
This certification sets a strong foundation for Subtle Medical’s ongoing innovation and growth in AI-powered medical imaging. Healthcare organizations can trust that Subtle Medical prioritizes safety, transparency, and quality in AI solutions that improve imaging workflows and patient care.
For more on AI governance and medical imaging software, visit Subtle Medical’s official website. To explore AI courses relevant to healthcare management and technology, check out Complete AI Training’s healthcare-related courses.
About Subtle Medical
Subtle Medical provides AI-powered imaging solutions that optimize scan efficiency and image quality in radiology. The company is recognized among CB Insights GenAI 50, AI 100, and Digital Health 150 companies, with deployments on over 900 scanners worldwide. Subtle Medical’s technology helps imaging centers and hospitals improve workflow efficiency, enhance scanner sustainability, and elevate patient outcomes.
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