Greenlight Guru Secures First ISO 42001 Certification for Medtech AI

The certification, audited by Prescient Security LLC, validates the company’s internal frameworks for designing, testing, and monitoring AI tools. By aligning with this international standard, Greenlight Guru provides medical device manufacturers with a documented audit trail, addressing increasing pressure from the FDA and the upcoming enforcement of the EU AI Act on August 2, 2026.

For device manufacturers, the shift toward mandatory AI risk management has made vendor qualification significantly more complex. Procurement teams and regulators now require concrete evidence that software vendors maintain oversight of their AI outputs. Greenlight Guru’s certification serves as a ready-made component for technical files and supplier qualification documentation, allowing clients to demonstrate compliance during regulatory reviews.

Robin Sterzer, Director of Security and Compliance at Greenlight Guru, emphasized that the move addresses the core tension between innovation and accountability in high-stakes environments. The company’s AI strategy focuses on automating manual documentation and clinical trial data tasks while ensuring that a qualified human remains in control of final decisions. This latest credential joins the company’s existing ISO 9001, ISO 27001, and SOC 2 Type II certifications, creating a comprehensive compliance framework for its global client base of over 1,000 medical device companies.