Histofy has been certified to ISO/IEC 27001 and ISO 13485, marking a major milestone in its commitment to excellence. The company now meets globally recognised standards for information security and medical device quality management. This achievement reinforces Histofy’s role in delivering trusted, high-performance AI solutions for healthcare.
Coventry, UK (9 July 2025) – Histofy, a UK-based developer of AI-powered pathology solutions, is proud to announce that it has achieved certification for both ISO/IEC 27001 and ISO 13485, with BSI as its notified body. These internationally recognised standards mark a significant milestone in Histofy’s mission to deliver secure, high-quality, and clinically robust AI technologies for improved healthcare provision.
ISO/IEC 27001 is the global standard for information security management, confirming that Histofy has implemented rigorous controls to protect sensitive data across its infrastructure, systems, and development pipeline. ISO 13485, the international standard for medical device quality management systems, verifies that Histofy’s processes meet strict regulatory and safety requirements for the development of medical-grade software.
“Quality is at the heart of everything we do as a company. Achieving these certifications demonstrates our commitment to building AI solutions that are not only innovative, but also safe, secure, and ready for real-world clinical use,” said Professor David Snead, Chief Medical Officer at Histofy. “They provide the foundation for wider adoption of our technology in environments where trust and reliability are essential.”
"Quality is at the heart of everything we do as a company"
Histofy develops AI solutions for pathology to advance both clinical diagnostics and drug development. From cancer screening to toxicologic assessment, its technology supports pathologists in making faster, more accurate, and insight-driven decisions. By embedding robust processes into every stage of development, Histofy ensures its tools are built for performance, transparency, and compliance.
“With ISO 27001 and ISO 13485 in place, we are well-positioned to deliver AI solutions that add real value to clinical practice – enhancing efficiency while ensuring patient safety,” said Dr Simon Graham, Chief Technology Officer at Histofy, who led the implementation of management systems for both certifications.
About Histofy
Histofy is an AI solution provider based in Coventry, UK, specialising in next-generation AI solutions for clinical diagnostics and drug development. Our transparent, data-efficient AI solutions are designed for scalability and real-world impact – supporting pathologists and scientists in reducing diagnostic workload, improving accuracy, and accelerating decision-making in tissue assessment across healthcare and life sciences.
For more information, please contact:
Dr Simon Graham
s.graham [at] histofy [dot] ai
www.histofy.ai