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Flo Health Earns ISO 13485 Certification for Its Quality Management System

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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.

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Play Yellow Tees Up as Charity Beneficiary of Inaugural Austin Championship to Support Children’s Healthcare

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Delta Air Lines to sponsor Play Yellow Sunday, celebrating local patient families and supporting Dell Children’s Medical Center through Children’s Miracle Network

AUSTIN, Texas, Nov. 11, 2026 /PRNewswire/ — Play Yellow, a fundraising program of Children’s Miracle Network (CMN), is excited to be part of the inaugural Austin Championship presented by Compliance Solutions, bringing its mission of supporting children’s healthcare to the course and the local community. Proceeds from the tournament will benefit Play Yellow and provide significant support to the local children’s hospital, Dell Children’s Medical Center, and the surrounding community.

Play Yellow unites the golf community to support children’s healthcare across the U.S. and Canada. Founded through a partnership between Jack and Barbara Nicklaus, Children’s Miracle Network and the PGA Tour, Play Yellow invites golfers, tournaments and fans to turn their passion for the game into life-changing care.

“Our partnership with the PGA Tour and events like the Austin Championship presented by Compliance Solutions reminds us what’s possible when a community comes together for kids,” said Becca Evans, National Director of Play Yellow, Children’s Miracle Network. “We’re grateful for every golfer, fan, and partner who helps make big change for all kids.”

Delta Air Lines Sponsors Play Yellow Sunday

Delta Air Lines is sponsoring Play Yellow Sunday. By wearing yellow and fundraising through golf, the Play Yellow community elevates the level of care at local children’s hospitals.

Ten patient families will join Children’s Miracle Network on the course, wearing caddie bibs featuring the Delta Air Lines logo. Some children will have the opportunity to walk a hole alongside a PGA Tour professional, while others will join the action by helping as honorary caddies on the 18th green. Among the participating children is Jett Payne, the local Children’s Miracle Network champion.

After a difficult delivery, Jett began experiencing seizures and was transferred to Dell Children’s Medical Center, where an MRI revealed multiple strokes that likely occurred before or during birth. He spent 12 days in the Neuro-NICU, where specialized care helped stabilize his seizures and support his recovery. Today, Jett is a thriving 2-year-old who is walking, talking, and exceeding milestones. He will be joined by his parents, Ryann and Brad Payne, and his brother, Briggs, age 9.

Supporting Dell Children’s Medical Center

Dell Children’s, a hospital within Children’s Miracle Network, has partnered with CMN for nearly 40 years. Since opening in 2007, Dell Children’s Medical Center has served as Central Texas’s only freestanding pediatric Level I trauma center, bringing world-class children’s healthcare to families in their own community. From pediatric heart and bone marrow transplants to expanding access to pediatric mental health care, Dell Children’s continues to advance what’s possible for children across Central Texas.

“Every day at Dell Children’s, we see the difference that access to specialized pediatric care makes in the lives of children and their families,” said Megan Campuzano, Senior Director, Annual Giving, Dell Children’s Medical Center. “The generosity of our community supports that care, allowing us to expand what we can do for children across Central Texas. We are grateful to Play Yellow, Children’s Miracle Network, the PGA Tour, and every supporter making this event a reality. It is meaningful to see our patient families recognized on such a special stage and to have our community unite behind a brighter future for all kids.”

Play Yellow Ambassadors Lead the Way

Helping bring the CMN mission to life on the course, Play Yellow’s ambassadors Patrick Fishburn, Hank Lebioda, Justin Lower, Kevin Roy, Max McGreevy, Peter Malnati, and Neal Shipley will also take the course in Austin, continuing to use their platforms to rally golfers, fans, sponsors, and communities around the shared mission of supporting children’s healthcare.

To learn more about Play Yellow, explore its ambassadors, start your own golf fundraiser, or find ways to get involved, visit playyellow.cmn.org.

About Children’s Miracle Network:

For more than 40 years, Children’s Miracle Network® has been a symbol of hope, elevating possibilities for every child in need of care. As the leading charity impacting children’s healthcare, we unite people, partners and programs to raise urgently needed funds for children’s hospitals across the U.S. and Canada.

Wherever you see our iconic balloon, you’ll find donors, corporate partners and fundraising programs joining forces to help hospitals meet their most critical needs—from life-changing care and advanced equipment to innovative research and family support. Every dollar raised benefits the local children’s hospital, bringing brighter futures within reach for all kids.

Learn more at cmn.org.

About Play Yellow:

Play Yellow, a Children’s Miracle Network program in partnership with Jack and Barbara Nicklaus and the PGA Tour, unites the golf community to turn their passion for the game by raising funds for life-changing care for all kids.

Media Contact:
Christina Vitale | cvitale@cmn.org | 908-839-2152

On-Site Contact:
Samantha Edwards | sedwards@cmn.org |812-243-2159

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SOURCE Children’s Miracle Network

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Gushine Brings Global Manufacturing Capabilities and Custom Battery Solutions to electronica 2026

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MUNICH, Nov. 11, 2026 /PRNewswire/ — Gushine Electronics, a specialist in custom lithium battery solutions, is showcasing its battery engineering expertise and international manufacturing capabilities at electronica 2026, held November 10–13 in Munich, Germany. At Hall A5, Booth 275, the company is presenting custom battery solutions for robotics, industrial automation, medical equipment, and industrial handheld devices.

Manufacturing Operations Across China and Vietnam

Founded in 2011 and headquartered in Zhuhai, China, Gushine provides custom battery pack development and manufacturing services for OEM customers worldwide.

Building on its established R&D and manufacturing operations in China, Gushine began production operations in Vietnam in 2025. The facility continues to develop its production processes and manufacturing capabilities, focusing on battery packs for handheld terminals and smart devices while complementing the company’s operations in China.

Custom Battery Solutions for Robotics and Industrial Applications

As automation expands across manufacturing, warehousing, and commercial services, equipment manufacturers face increasingly diverse requirements for battery runtime, performance, safety, and system integration.

At electronica 2026, Gushine is highlighting custom battery solutions for automated guided vehicles (AGVs), autonomous mobile robots (AMRs), warehouse automation equipment, and commercial service robots.

The company is also showcasing battery solutions for robotic lawn mowers, cleaning robots, medical carts, rugged handheld terminals, and surveying instruments.

Gushine’s engineering capabilities span cell selection, mechanical design, battery management system (BMS) development, and communication integration. This approach enables battery systems to be tailored to the operating conditions and technical requirements of different applications.

Strengthening Long-Term Partnerships in Europe

Europe’s diverse innovation ecosystem, particularly in industrial manufacturing, automation, medical technology, and specialized equipment, offers opportunities for long-term technical collaboration.

“European companies demonstrate strong engineering expertise and a commitment to innovation. We believe meaningful innovation begins with understanding real-world application needs. By working closely with our customers, we aim to help turn their ideas into reliable, market-ready products through customized battery engineering,” said Jack Yu, Vice President at Gushine.

Gushine remains committed to strengthening relationships with European OEMs, building lasting technical partnerships, and supporting the development of next-generation equipment and technologies.

Visit Gushine at electronica 2026: Hall A5, Booth 275, Messe München, November 10–13.

View original content to download multimedia:https://www.prnewswire.co.uk/news-releases/gushine-brings-global-manufacturing-capabilities-and-custom-battery-solutions-to-electronica-2026-302936635.html

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AICPA & CIMA’s first-ever China’s ENGAGE Asia Conference 2026 concludes the future of accounting and finance will be defined by trust, talent, and human judgement

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SHANGHAI, Nov. 12, 2026 /PRNewswire/ — ENGAGE Asia Conference 2026 brought together 600 business, finance and technology leaders from across Asia and around the world to explore the trends, opportunities and challenges shaping the future of organisations and the accounting and finance profession.

Under the theme The Next Wave – Transformative Innovation, discussions covered the impact of AI on finance; business and leadership; the future of talent and workforce transformation; long-term value creation; China’s global ambition; and the growing importance of trust in an increasingly complex world.

Throughout the two-day conference, speakers and delegates also examined how organisations can harness technology while strengthening human judgment, adaptability and ethical leadership, reinforcing the critical role accounting and finance professionals play in driving innovation, resilience and sustainable growth in a rapidly changing global economy.

Mark Koziel, CPA, CGMA, President & CEO of AICPA & CIMA said, “The ENGAGE Asia Conference 2026 has demonstrated the tremendous energy, innovation and leadership emerging from China and Asia’s business community. The conversations, together with the insights from our RISE2040 initiative, reinforce that the future of accounting and finance will be defined not only by technological advancement, but by our ability to combine AI with trust, talent and human judgment. Accounting and Finance professionals have a vital role to play in creating sustainable value and helping businesses thrive. The ideas and connections sparked here in Shanghai will help shape the next wave of leadership and progress.”

Vicky Li, Vice President, North Asia, AICPA & CIMA, said, “Hosting the ENGAGE Asia Conference in Shanghai for the first time, in conjunction with CIMA China’s 20th anniversary, reflects both the growing importance of both China and Asia in the global economy and the region’s commitment to innovation and talent development. Over the past two days, we have brought together diverse perspectives from business, accounting, finance, technology and academia to explore how organisations can thrive in a rapidly changing world. We are proud to provide a platform that equips professionals with the insights, skills and connections needed to lead with confidence in the future.”

In August 2027, the Engage Asia Conference moves to Malaysia.

View original content to download multimedia:https://www.prnewswire.com/apac/news-releases/aicpa–cimas-first-ever-chinas-engage-asia-conference-2026-concludes-the-future-of-accounting-and-finance-will-be-defined-by-trust-talent-and-human-judgement-302936798.html

SOURCE AICPA & CIMA

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