Flo Health Earns ISO 13485 Medical Device Quality Certification, Adding to Its ISO Security and Privacy Credentials

Independent audit by Scarlet returned no major findings; certification supports Flo's route to CE and UKCA marking and aligns with the FDA's Quality Management System Regulation

LONDON--(BUSINESS WIRE)--Flo Health, the #1 women's health app used by more than 500 million people worldwide, has earned ISO 13485 certification, the international standard for quality management systems in medical devices. The certification follows an independent audit of Flo's quality management system (QMS) by Scarlet, a government-accredited certification body that specializes in AI medical devices. The audit returned no major findings.

ISO 13485 requires consistent control over how a company designs its products, manages risk, oversees suppliers, maintains traceability and takes preventive and corrective action. Certification is maintained through annual surveillance audits, with full recertification every three years.

“Rigorous quality for the benefit of our users is paramount to how Flo operates,” said Tauseef Mehrali, VP of Regulatory Affairs at Flo. “ISO 13485 certification is independent validation that our processes are built to meet the standards regulators and customers hold us to.”

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

A certified QMS supports the conformity assessment route for CE and UKCA marking. Flo's QMS also closely aligns with the U.S. Food and Drug Administration's Quality Management System Regulation (QMSR), which incorporates ISO 13485 by reference. Flo says the certification gives it a foundation to apply the same rigor to future regulated digital health products.

ISO 13485 builds on Flo's existing ISO 27001 and ISO 27701 certifications for information security and privacy management. More on how Flo protects user data is available on its Privacy Portal.

About Flo Health

Flo is the #1 Health and Fitness app worldwide and the #1 OB-GYN-recommended platform for period and cycle tracking. In 2024, Flo became the first European femtech unicorn following an investment from General Atlantic, and it now supports 80 million monthly active users (MAUs) worldwide. Powered by a network of more than 100 medical experts, Flo guides women through every stage of their health journey, from menstruation to conception, pregnancy and menopause, with cycle and ovulation tracking, personalized health insights, daily educational content and a private community for users to share questions or concerns. Through its Pass it on Project, Flo has donated more than 29 million Flo Premium subscriptions to women in need, with the aim of reaching up to one billion. A leader in privacy and security, Flo's Anonymous Mode feature was recognized as one of TIME's Best Inventions 2023 and was named a finalist for Fast Company's 2023 World Changing Ideas Awards.

For more information, please visit flo.health.