Flo Health Earns ISO 13485 Certification for Its Quality Management System

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ISO 13485 certification validates the quality management system of the women's health app against the global standard for medical devices LONDON, Nov. 11, 2026 /PRNewswire/ -- Flo…

ISO 13485 certification validates the quality management system of the women's health app against the global standard for medical devices

LONDON, Nov. 11, 2026 /PRNewswire/ -- Flo Health, the #1 women's health app used by more than 500 million people worldwide, has achieved ISO 13485 certification, following an independent audit of its quality management system conducted by Scarlet, a government-accredited certification body specialized in AI medical devices. This means an independent third-party auditor has verified the integrity of our quality management system (QMS) behind how we would design, build and maintain medical device software.

ISO 13485 is the internationally recognized standard for QMS in the medical device industry. It requires organizations to demonstrate consistent control over design, risk management, supplier oversight, traceability, and preventative and corrective action.

Flo's QMS runs on Ketryx, an intelligent lifecycle platform for regulated product development, which provides continuous compliance and end-to-end traceability from requirements through risk, verification and release.

As healthcare organizations and patients increasingly rely on digital health tools and connected devices, independent verification of quality practices is essential to trust and provides users with assurance that products are developed and maintained to the highest standards.

Quality, safety, and privacy are cornerstone to how Flo operates. Flo also holds ISO 27001 and ISO 27701 certifications for its information security and privacy management systems. Flo's latest ISO 13485 certification came back with no major findings.

Achieving ISO 13485 marks the next step in Flo's development, as independently verifying each innovation is designed with quality and safety in mind. Unlike a one-time assessment, maintaining ISO 13485 requires ongoing independent oversight, including annual surveillance audits and full recertification every three years.

"Rigorous quality for the…

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