Flo Health earns ISO 13485 certification for medical device software
Flo Health has earned ISO 13485 certification for the quality management system behind how it designs, builds and maintains medical device software. The women's health app says the certification followed an independent audit by Scarlet, a government accredited certification body specialized in AI medical devices.
- Flo Health earned ISO 13485 certification after an independent audit.
- The audit was conducted by Scarlet, a government accredited certification body.
- Flo said the assessment returned with no major findings.
- The company's system runs on Ketryx for compliance and traceability.
- Maintaining certification requires annual surveillance audits and recertification every three years.
Independent review of Flo's quality system
ISO 13485 is an internationally recognized standard for quality management systems in the medical device industry. It requires organizations to demonstrate consistent control over areas including design, risk management, supplier oversight, traceability, and preventive and corrective action.
According to Flo Health, Scarlet's audit verified the integrity of the company's quality management system. Flo said its latest certification assessment returned with no major findings. The company described the certification as independent third party validation of the processes supporting its medical device software development.
"Rigorous quality for the benefit of our users is paramount to how Flo operates," said Tauseef Mehrali, Flo's VP of Regulatory Affairs. He said the certification provides "independent validation that our processes are built to meet the standards regulators and customers hold us to."
The system supports regulated product development
Flo's quality management system runs on Ketryx, an intelligent lifecycle platform for regulated product development. The company said the platform provides continuous compliance and end to end traceability from requirements through risk, verification and release.
Flo said a certified quality management system is the foundation for developing software as a medical device. It supports 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.
The company also holds ISO 27001 and ISO 27701 certifications for its information security and privacy management systems. Flo said privacy, security, quality and safety are foundational to its product development and business practices.
What the certification means for Flo users
The certification is not a one time assessment. Maintaining ISO 13485 requires ongoing independent oversight, including annual surveillance audits and full recertification every three years. That gives Flo a continuing external review process for its quality management practices.
Flo said the certification gives it a foundation to extend the same level of quality and safety controls to regulated digital health products in the future. The company says its app is used by more than 500 million people worldwide and supports 80 million monthly active users. Its services include cycle and ovulation tracking, personalized health insights, educational content and a private community.
In 2024, Flo became the first European femtech unicorn following an investment from General Atlantic, according to the company. Its certification adds a formal medical device quality standard to the privacy and security measures Flo says it uses to build user trust.
PR Newswire: Flo Health Earns ISO 13485 Certification for Its Quality Management System
