#London #United Kingdom #Quality Management #Flo Health #Business Technology

Flo Health Achieves ISO 13485 Certification

Flo Health, the foremost women's health application utilized by more than 500 million individuals globally, proudly announces its achievement of ISO 13485 certification. This recognition underscores the company's unwavering commitment to delivering quality and safety within its innovative healthcare solutions.

ISO 13485 is an internationally acknowledged standard concerning quality management systems (QMS) applicable to the medical device sector. By meeting this benchmark, Flo Health confirms its ability to consistently control key elements within the design, risk management, supplier oversight, traceability, and both corrective and preventive actions across its software development processes.

The certification was granted following a scrutinizing independent audit by Scarlet, a certification authority accredited by the government and recognized for its expertise in evaluating AI-driven medical devices. This third-party validation adds a layer of integrity to the QMS underpinning the design and maintenance of Flo’s software as a medical device.

As the reliance on digital health tools increases among healthcare providers and patients alike, independent verification of a company’s quality practices is more important than ever. This certification not only enhances user confidence but also affirms that Flo's products are crafted and sustained to meet the highest medical standards.

Robust Quality Practices

Flo Health ensures that quality, safety, and privacy are foundational to its operations. In addition to ISO 13485, the company has obtained ISO 27001 and ISO 27701 certifications, which reflect its strong commitment to information security and privacy management. Notably, the recent ISO 13485 evaluation yielded no critical findings, symbolizing the strength and reliability of Flo’s processes.

Achieving this certification is a significant stride forward for Flo Health, showcasing their dedication to ensuring that all innovations incorporate quality and safety from the ground up. Unlike a singular assessment, maintaining ISO 13485 necessitates continual oversight through annual surveillance audits, with a full recertification process occurring every three years.

Tauseef Mehrali, the Vice President of Regulatory Affairs at Flo, emphasizes, "Rigorous quality for the benefit of our users is paramount to how Flo operates. ISO 13485 certification is an 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."

The certified QMS serves as a cornerstone for the software development of medical devices, demonstrating a disciplined approach to design control and risk management. This certification ensures compliance with both CE and UKCA marking requirements as well as aligns with the U.S. FDA’s Quality Management System regulations, which incorporate ISO 13485 by reference.

Looking to the Future

With this solid foundation, Flo Health is well-positioned to extend the same rigorous standards to future digital health products that will cater to a growing market. As a leading platform in women’s health, Flo is dedicated to ensuring every stage of a woman’s health journey—spanning menstruation, conception, pregnancy, and menopause—is supported effectively.

Founded on a network of more than 100 medical experts, Flo offers personalized health insights and daily educational content while fostering a community for users to engage and share their experiences. Their commitment to improving health literacy is evident through the “Pass it on Project,” which has provided over 29 million Flo Premium subscriptions to women in need.

As Flo Health continues to push boundaries in the health tech space, the recognition of ISO 13485 further solidifies its reputation as a trusted source for health management, aligning with its vision to enhance the lives of women around the world.

For further details, please visit Flo Health.