Greenlight Guru has recently achieved ISO/IEC 42001:2023 certification for its Artificial Intelligence Management System, marking a significant milestone in AI governance for medtech. This certification applies to the company's electronic Quality Management System (eQMS) and clinical electronic data capture (EDC) products, providing medical device companies with verified documentation for audits and vendor qualifications.
The ISO 42001 certification assesses an organization's ability to manage AI governance, risk, and lifecycle controls effectively. Greenlight Guru is the first medtech-focused provider to publicly announce this certification for both eQMS and EDC products, which is crucial as regulatory bodies like the FDA and the EU are increasingly focusing on AI governance in their guidelines. As compliance becomes a regulatory requirement, documented AI risk management is now essential for vendor qualification.
Greenlight Guru's achievement demonstrates its commitment to responsible AI development and deployment. The certification serves as third-party evidence that the company has the necessary governance and monitoring in place to ensure AI capabilities are effectively integrated into its quality and clinical solutions. This is particularly important as medical device companies navigate the complexities of regulatory scrutiny and compliance obligations.
In an industry where trust in AI outputs is paramount, Greenlight Guru provides assurance to its clients that its AI governance meets rigorous standards. The company’s certifications, including ISO 9001 for quality and ISO 27001 for information security, further solidify its position as a leader in the medtech space, offering comprehensive, audit-ready documentation that meets the compliance demands of regulated industries.