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 benefit of our users is paramount to how Flo operates,” said Tauseef Mehrali, VP of Regulatory Affairs for Flo. “ISO 13485 certification is independent validation that our processes are built to meet the standards regulators and customers hold us to. It gives us a stronger foundation to keep improving the value and caliber of our infrastructure and policies.”

Certification is only one part of how Flo earns and keeps customer trust. We build quality and risk management principles directly into product development, where privacy and security are seen as foundational business drivers.

A certified QMS is the foundation for developing software as a medical device. It demonstrates disciplined design controls and risk management, underpins the conformity assessment route for CE and UKCA marking, and closely aligns with the U.S. Food and Drug Administration’s Quality Management System Regulation, which incorporates ISO 13485 by reference. It gives Flo the foundation to extend the same rigor to the regulated digital health products in the future.

About Flo Health
Flo Health 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 now supports 80 million monthly active users (MAUs) worldwide. Powered by a network of over 100+ medical experts, Flo guides women through every stage of their health journey – from menstruation to conception, pregnancy, and menopause – offering curated 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 29M Flo Premium subscriptions to improve health literacy to women in need, aiming to reach up to one billion. A leader in privacy and security, Flo Health’s Anonymous Mode feature was recognized as one of TIME’s Best Inventions 2023 and also named a finalist for Fast Company’s 2023 World Changing Ideas Awards as part of the company’s commitment to privacy.

For more information, please visit https://flo.health.

PR contact 
Samantha Wannemacher
Flo Health
s_wannemacher@flo.health 

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SOURCE Flo Health Inc.