Medical device companies face a growing problem: how to prove their AI tools are safe when regulators and hospitals demand proof. Greenlight Guru, an Indianapolis-based software firm, now offers an answer backed by an independent certification. The company announced it has earned ISO/IEC 42001:2023 certification for its Artificial Intelligence Management System.
This is the first international standard written specifically for AI governance. A firm called Prescient Security LLC conducted the audit.
Greenlight Guru builds quality management, product development, and clinical data software for medical device companies. Its electronic Quality Management System and Electronic Data Capture products now carry this stamp. The certification covers how AI is designed, trained, tested, and deployed across those platforms.
The stakes are concrete. Hospital systems and regulators like the FDA increasingly ask for evidence that AI tools are safe, fair, and transparent before they approve a device or let it into procurement pipelines.
Without that evidence, a device can stall. Patients may wait longer for treatments. Companies can lose money on years of development.
What the certification does in practical terms: when a medical device company uses Greenlight Guru’s software and faces an audit, they can point to the ISO 42001 certification as third-party evidence. The audit covers the full AI lifecycle — from initial design through training, testing, and ongoing deployment. It is not a guarantee that any specific device is safe.
It is a guarantee that the AI tools used to build and test that device are managed under a recognized governance framework. For patients, the logic is straightforward.
AI is being used to design devices and run clinical trials. That AI can introduce bias, errors, or hidden risks if not governed properly. Independent certification is one way to catch those problems before they reach a patient.
The standard requires companies to show how they handle data quality, model transparency, and fairness. It forces them to document decisions.
Medical device companies already face intense scrutiny. Their software must comply with FDA quality system regulations, ISO 13485, and other standards. Adding AI governance on top of that creates complexity.
Greenlight Guru’s certification simplifies one piece of that puzzle. A company using their software does not have to build its own AI governance system from scratch. It can rely on the platform’s certified processes.
The certification is voluntary. No law requires it.
But the market is shifting. Hospital systems and regulators are starting to ask harder questions. They want proof, not promises.
A certification like this gives them something concrete to check. Greenlight Guru did not disclose how long the certification process took or what it cost.
The company said the certification gives medical device firms independently verified evidence for audits and vendor qualification. That matters because audits can delay product launches by months. A ready-made answer can speed things up.
The standard itself is new. ISO/IEC 42001 was published in 2023. Few companies in any industry have earned it.
Greenlight Guru is among the first in medtech. That gives them a market advantage, at least for now.
Competitors will follow. The question is whether the certification becomes a baseline requirement, like ISO 13485 is today, or remains a differentiator. For now, the practical effect is clear.
When a hospital system asks a device company about AI governance, the company can open a file and show the certificate. That is a small thing.
In procurement, small things decide which products get used and which get left behind.
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