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How Flo Transitioned from Unregulated to Regulated Development—Without Losing Speed

Flo Health is the world’s leading women’s health platform with 430 million users, 77 million monthly active users, and a 200+ person engineering team. The company set out to deliver more clinically valuable, FDA-grade features without slowing its fast, experiment-driven culture that ships updates daily and runs more than 1,000 tests each year.

To add a QMS and regulatory controls without disrupting developer experience or velocity, Flo used Ketryx’s AI-native compliance platform, embedding regulated workflows directly into Jira and GitHub. In under 90 days, Flo moved from an unregulated environment to a regulated, audit-ready organization and stood up an AI-ready QMS, all while developers working on regulated features experienced no loss in velocity or job satisfaction.

Impact

90 days

Time to create and implement QMS

Zero development slowdown

Continued releases at consumer speed

System of systems architecture

Scalable foundation for multifunction devices

Industry

FemTech

Device Type

SaMD

Tech Stack

Jira, GitHub

Requirements: Medical-Grade Quality at Consumer-Product Speed

To unlock deeper clinical insights and deliver greater value for users, Flo needed to establish a foundation for building regulated software. As the team evaluated tooling options, they identified four critical requirements:

• Preserve engineering velocity and culture of innovation: Maintain Flo’s rapid release cadence for regulated features while protecting its automation-first, experiment-driven engineering culture.
• Avoid friction and manual burden on developers: Keep engineers in Jira, GitHub, and existing CI/CD pipelines without adding new tools or manual documentation. Compliance artifacts should be generated automatically as a byproduct of normal work. Flo explicitly set a goal of no decrease in developer satisfaction for teams working under the new QMS.
• Create a QMS built for AI and modern SaMD: Stand up Flo’s first ISO 13485-compliant quality management system with processes designed to support frequent releases and lifecycle changes for AI/ML-enabled features.
• Support a multi-function, system-of-systems architecture: Technically isolate device from non-device functionality so only true medical device components follow QMS controls, keeping the rest of the Flo app shipping at consumer speed.

Ketryx Solution: Developer-First, AI-Ready Compliance

Ketryx enabled Flo to implement a modern, compliant QMS without adopting legacy systems or forcing engineers into new workflows.

• 90-day QMS deployment, onboarding, and readiness: Ketryx provided guided configuration, templates, and training, enabling Flo to stand up a fully functioning QMS, map existing processes, and train teams in under 90 days (work that Flo estimated to take one year).
• Automated compliance inside existing developer workflows: Ketryx connects to Jira, GitHub, and CI/CD pipelines to automatically capture requirements, risks, tests, builds, and releases. Engineers ship code as usual while the DHF, traceability matrices, and documentation are generated automatically in the background.
• Built-in support for AI/ML-enabled, multi-function products: With native support for traceability, versioning, and systems of systems, Ketryx gives Flo the regulatory infrastructure needed for AI-powered features and multi-function devices without placing the entire app under stringent QMS processes.

Business Outcomes: The New Playbook for Digital Health

With Ketryx, Flo achieved regulatory readiness at lightspeed.

• 90-day launch of a fully functional regulated SDLC: End-to-end QMS setup, process design, training, and tool integration completed in 90 days.
• No slowdown for teams under QMS: Teams working on regulated features continue to ship at a biweekly cadence, with no added friction or separate compliance tooling—validating Flo’s goal of preserving developer satisfaction and speed.
• Scalable foundation for AI-enabled innovation and multifunction devices: Flo now has the compliance infrastructure and system of systems architecture to support multiple regulated product lines, AI-driven capabilities, and a clear device/non-device boundary, establishing a repeatable playbook for digital health companies going regulated.
• First regulated product work executed and documented in Ketryx: Regulated design activities, reviews, and releases are performed and documented in the same tools engineers already use, backed by automated traceability and audit-ready records.

"Delivering quickly is core to our mission because faster releases mean better health outcomes for our users. Ketryx is the only partner we found that gave us the ability to maintain our velocity while achieving medical-grade quality.”

Roman Bugaev

CTO

“Regulatory readiness for us means compliance by design: a QMS that’s inherently built into how the company operates, not an add-on. Ketryx enabled us to build a QMS smart enough to apply the strictest processes only where they’re truly needed.”

Tsimafei Savitski

Chief Legal & Compliance Officer