Case Study: Flo Health achieves regulated development without slowing down with Ketryx

Flo Health launches regulated development in 90 days with Ketryx

Flo Health, the world's leading women's health platform, faced the challenge of transitioning its development process to meet FDA and ISO 13485 regulations without sacrificing its fast-paced, experiment-driven engineering culture that ships updates daily. The company needed to implement a Quality Management System (QMS) that would not add friction or manual burden for its developers working on regulated software as a medical device (SaMD) features. To solve this, Flo partnered with Ketryx and used its AI-native compliance platform.

Ketryx embedded regulated workflows directly into Flo's existing tools like Jira and GitHub, automatically generating compliance artifacts as a byproduct of normal work. This solution enabled Flo to stand up a fully functioning, audit-ready QMS in under 90 days. The key result was that teams working on regulated features experienced zero slowdown and continued to release updates at their previous biweekly cadence, all while establishing a scalable regulatory foundation for future AI-enabled products.

Flo Health