Flo Health achieves medical device quality certification

Period tracking app Flo Health has secured ISO 13485 certification for its quality management system following an independent audit.

The certification confirms that the company’s processes meet an internationally recognised standard for quality management in the medical device industry.

It was awarded following an audit by Scarlet, a government-accredited certification body specialising in AI medical devices, which reported no major findings.

ISO 13485 requires organisations to demonstrate consistent controls over product design, risk management, supplier oversight, traceability and corrective action.

For Flo, the certification independently verifies the quality management processes it would use to design, develop and maintain medical device software.

The company’s quality management system runs on Ketryx, a platform that supports regulated product development by monitoring compliance and tracking requirements, risks, verification and product releases.

Maintaining ISO 13485 certification requires annual surveillance audits and full recertification every three years.

Tauseef Mehrali, vice president of regulatory affairs at Flo, said: “Rigorous quality for the benefit of our users is paramount to how Flo operates.

“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 calibre of our infrastructure and policies.”

Flo already holds ISO 27001 and ISO 27701 certifications for its information security and privacy management systems.

The company said the latest certification would support the development of regulated digital health products in the future.

A certified quality management system is part of the regulatory framework for medical device software, supporting conformity assessments for CE and UKCA marking.

ISO 13485 also aligns with the US Food and Drug Administration’s Quality Management System Regulation, which incorporates the standard by reference.

Flo provides period and ovulation tracking, pregnancy information and menopause-related health content.

The company reports 80m monthly active users worldwide and says its app has been used by more than 500m people.

Flo became the first European femtech unicorn in 2024 following an investment from General Atlantic.

It also operates the Pass it on Project, through which it has donated more than 29m Flo Premium subscriptions to improve health literacy among women in need.