The certification covers AI governance across the company's eQMS and EDC products, giving medical device companies independently verified evidence for audits and vendor qualification

INDIANAPOLIS, July 2, 2026 /PRNewswire/ -- Greenlight Guru, which builds quality management, product development, and clinical data software for medical device companies, today 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 organization has the governance, risk management, transparency, and lifecycle controls to balance AI innovation with safety, from initial design through deployment and continuous monitoring.

Why this matters

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.

What this means

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.

Over the past several years, Greenlight Guru has built AI capabilities across its quality, product development, and clinical data solutions, each designed to remove a specific friction medtech teams carry: the time spent hunting for records across a quality system, the rework caused when requirement issues surface too late, the hours skilled people lose to documentation tasks a system should handle, and the manual repetition that slows clinical data operations, data monitoring based on manual exports from outdated clinical data platforms, and inefficient site management in clinical trials.

Every capability is designed so that a qualified person is in control of the output. Greenlight Guru built AI to take the manual work off skilled people while keeping the decisions that matter in their hands, because in a regulated environment, speed without oversight is a liability. ISO 42001 certification is the independent proof that the governance behind it meets the bar.

"Every vendor in medtech is talking about AI. The question our customers ask is whether they can trust what it produces when someone is in the room asking how a decision was made," said Robin Sterzer, Director of Security and Compliance at Greenlight Guru. "This certification is independently verified proof that how we govern AI meets that bar. When a customer needs a documented answer on vendor AI governance, they have one."

Greenlight Guru now holds ISO 42001 (AI governance), ISO 9001 (quality), ISO 27001 (information security), and SOC 2 Type II (operational controls) across all products, giving customers audit-ready, verified evidence across AI governance, quality, data security, and continuous operating effectiveness, a trust framework purpose-built for the compliance demands of regulated industries.

About Greenlight Guru

Greenlight Guru builds software for medical device companies, and only for medical device companies. Trusted by more than 1,000 device companies worldwide, Greenlight Guru provides quality management, product development, and clinical data solutions backed by people who have done the work. Teams adopt the solutions that fit their stage and add more as they grow. For more information, visit greenlight.guru.

 

 

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SOURCE Greenlight Guru