Greenlight Guru, which builds quality management, product development, and clinical data software for medical device companies, announced it has achieved ISO/IEC 42001:2023 certification for its Artificial Intelligence Management System. The certification, conducted by Prescient Security LLC, covers how AI is designed, trained, tested, deployed, monitored, and updated across all three of its products, spanning its eQMS and clinical electronic data capture (EDC) solutions.
The scope of Greenlight Guru's ISO 42001 certification covers both its eQMS and EDC products, a combination no other medtech-focused quality management or EDC provider has publicly announced. The standard evaluates whether an organisation has the governance, risk management, transparency, and lifecycle controls to balance AI innovation with safety, from initial design through deployment and continuous monitoring.
Notified bodies, the FDA, and internal auditors are asking medical device companies how their quality management and clinical software vendors govern AI. Procurement teams increasingly require documented evidence of AI risk management as part of vendor qualification. Regulators on both sides of the Atlantic are turning that expectation into formal requirements: the FDA has made AI governance a central focus of its evolving guidance on AI-enabled medical devices, while the EU AI Act begins enforcement on August 2, 2026, for device companies with products on the European market. Whether you're navigating FDA scrutiny or EU compliance obligations, documented AI risk management is becoming a regulatory expectation, not a preference.
Greenlight Guru has demonstrated, under independent audit, that it has the governance structure, risk controls, accountability, and monitoring to develop and deploy AI responsibly across its quality, product development, and clinical solutions. Customers can reference the certificate as third-party evidence in supplier qualification documentation, technical files, and audit responses. It is available on request at trust.greenlight.guru.
The certification governs how Greenlight Guru builds and governs AI internally. The company continues to lead the medtech industry in best practices for how AI capabilities are built, adopted, and used in a regulated environment. This certification, and a consistent, intentional, customer-and-regulation-driven approach to AI development and iteration, prove that.
