INDIANAPOLIS, July 2 — Greenlight Guru, a company that builds quality management, product development, and clinical data software for medical device companies, has achieved ISO/IEC 42001:2023 certification for its Artificial Intelligence Management System. The certification, announced today, covers how AI is designed, trained, tested, and deployed across the company’s electronic Quality Management System (eQMS) and Electronic Data Capture (EDC) products. This gives medical device companies independently verified evidence for audits and vendor qualification, the company said.
This is the first international standard specifically for AI governance. For medtech firms, the certification matters because regulators and hospital systems increasingly ask for proof that AI tools are safe, fair, and transparent before they approve devices or allow them into procurement pipelines.
The certification was conducted by Prescient Security LLC. Greenlight Guru’s software is used by medical device companies to manage everything from design controls to clinical trial data, and the AI components within those platforms now carry an independent stamp of approval. What this means in practical terms: when a medical device company uses Greenlight Guru’s software and faces an audit from regulators or a hospital system, they can point to the ISO 42001 certification as third-party evidence that the AI tools in the platform meet international governance standards.
The certification covers the full lifecycle of AI — from initial design through training, testing, and ongoing deployment. For patients, the encouraging part is that this kind of certification helps ensure the AI used in medical device development and clinical trials is being managed responsibly.
It does not guarantee a specific device is safe, but it does mean the software tools used to build and test that device have passed an independent review of their AI governance practices. The certification arrives at a time when regulators worldwide are paying closer attention to AI in healthcare. The ISO 42001 standard provides a framework for organisations to manage risks, ensure transparency, and maintain accountability when using AI systems.
Greenlight Guru’s achievement means medical device companies using their platform can check one more box during regulatory audits. Early findings from the certification process suggest that independent verification of AI governance is becoming a baseline expectation rather than a differentiator. Medtech firms that cannot demonstrate such governance may face questions from regulators and hospital systems in the coming years.
Greenlight Guru is based in Indianapolis. The company builds software specifically for the medical device industry, a sector where regulatory compliance is not optional and where mistakes can have direct consequences for patient safety.
The ISO 42001 certification adds a layer of assurance for the AI components embedded in their quality and clinical solutions. Patients should talk to their doctors if they have questions about how AI is used in their medical care or in the development of devices they might receive. This certification is a step toward greater transparency, but individual clinical decisions remain between patients and their healthcare providers.
Sources
- Greenlight Guru achieves ISO 42001 certification for AI
- Greenlight Guru achieves ISO 42001 certification for AI …
