Medical device software company Greenlight Guru now holds a certification that regulators and hospital purchasing departments are starting to demand: ISO/IEC 42001:2023. The Indianapolis-based firm announced the certification Tuesday, covering its entire Artificial Intelligence Management System. This is the first international standard written specifically for AI governance.
It covers how AI is designed, trained, tested, and deployed. For Greenlight Guru, that means the AI components inside its electronic Quality Management System and Electronic Data Capture products have passed a third-party check.
The audit was done by Prescient Security LLC. Why this matters for medical device companies is straightforward. When a regulator or a hospital system audits a device maker, they increasingly want proof that the AI tools used in product development and clinical trials are safe, fair, and transparent.
Greenlight Guru’s certification gives its customers an independent document to hand over during those checks. The certification does not guarantee a specific medical device is safe.
That is a separate process. What it does guarantee is that the AI management system Greenlight Guru uses to build and run its software meets the international governance standard. The audit looked at the full AI lifecycle — from the initial design phase through training, testing, and ongoing deployment.
Greenlight Guru’s software is already used by medical device companies to manage design controls, clinical trial data, and other regulatory requirements. The AI components within those platforms now carry an independent stamp of approval. For the companies using that software, it simplifies vendor qualification.
They do not have to run their own audit of the AI governance practices. The ISO certification covers that.
The practical effect for patients is indirect but real. When AI tools used in medical device development and clinical trials are managed under a certified governance system, there is less chance of hidden bias or sloppy testing. The certification does not eliminate risk, but it creates a documented, auditable framework for managing it.
Hospital systems and regulators have been pushing for this kind of verification. Without it, a device maker using AI-assisted software has to explain and defend its AI governance practices from scratch every time it faces a new auditor.
With a third-party certification like ISO 42001, the explanation is already done. Greenlight Guru is not the only company pursuing this certification, but it is among the first in the medical device software space to announce it. The standard itself was published in 2023.
Adoption is still early. For medical device firms, the pressure to have certified AI governance will likely grow as regulators in Europe and the United States tighten their requirements around software as a medical device and AI-driven clinical tools. The certification covers only Greenlight Guru’s own AI management system.
It does not extend to the AI systems that its customers build using the platform. Each medical device company remains responsible for its own AI governance.
But the certification means the foundation — the software platform itself — has been independently verified. That is one less variable for a device maker to worry about during an audit.
Sources
- Greenlight Guru achieves ISO 42001 certification for AI governance …
- 68 Checkboxes to Trust: What ISO 42001 Certification Actually Takes
