Watmind USA needed to transform its limited distribution-focused quality system into a fully compliant, scalable framework to secure FDA authorization, coordinate with overseas manufacturing, and deliver reliable, high-volume at-home diagnostic testing to the U.S. market.
Results
Watmind USA successfully delivered over 5 million FDA-authorized at-home test kits with an exceptionally low complaint rate, earning widespread trust from families and healthcare professionals while setting a new standard for reliable, accessible diagnostics.
"As a small company with limited resources, Rook Quality Systems was critical to our success. Rook implemented an ISO-13485 compliant QMS, their Taiwan team audited our critical vendors in China, and they manage all our regulatory communications. Thank you!"
Claudio Hanna
Chief Operating Officer, Watmind USA
About Watmind USA
Watmind USA is an innovative diagnostics company focused on delivering rapid, accurate at-home testing solutions. Their flagship product, the SpeedySwab™ COVID-19 and Flu A/B test, is widely trusted by consumers and healthcare professionals for its clinical reliability and ease of use.
As a small startup entering the U.S. market, Watmind USA had a bold vision: make lab-quality diagnostic testing accessible to the public withfast, convenient at-home solutions. From the beginning, Rook Quality Systems (Rook) served as an essential partner, guiding Watmind USA through complex regulatory and quality challenges to become a leading player in the diagnostics space. With over five million units sold and a remarkably low complaint rate,Watmind USA’s success has been built on a foundation of compliance, quality, and continuous support from Rook.
The Challenges: Narrow QMS Scope + Navigating Complex Global Regulations
In September 2022, Watmind USA approached Rook seeking assistance with enhancing their Quality Management System (QMS) and navigating international regulatory requirements. WatmindUSA's SARS-CoV-2 detection tests were developed in collaboration with a Chinese manufacturer, which presented unique challenges in aligning expectations and regulatory compliance, particularly as they pursued an Emergency Use Authorization (EUA) for their combined COVID-19 + Flu A/B detection device.
Our Solution: End-to-End Quality & Regulatory Support
Rook served as an embedded quality and regulatory partner, delivering full-service support across multiple areas:
QMS Expansion
Watmind USA needed to upgrade its QMS to a system with a broader scope that complied with FDA requirements. Their initial QMS was focused primarily on distribution activities and did not fully address the comprehensive needs of a legal manufacturer from the FDA's perspective. To address this, Rook updated their QMS to include design & development activities, management of product labeling, and product inspection, and introduced the diagnostics firm to Greenlight Guru, a system capable of supporting the QMS scope expansion.
Regulatory Guidance
Navigating regulatory requirements was another significant challenge faced by Watmind USA. With offices in the United States and the APAC region, Rook provided comprehensive support on two product lines:
SpeedySwab™ COVID-19 Test:
Rook's U.S. and APAC teams collaborated with Watmind USA’s Chinese manufacturer to ensure the data and reports supporting the shelf-life were clear and met the FDA’s expectations.
The U.S. team compiled the application and interfaced with the FDA on correspondence related to the COVID-19 test shelf-life extension.
SpeedySwab™ COVID-19 + Flu A/B Test:
The Rook teams supported FDA submission preparation by gathering and reviewing necessary data from both WatmindUSA and their Chinese manufacturer.
Rook's U.S. team compiled applications and interfaced with the FDA on the combined COVID-19 and Flu A/B EUA.
Rook's APAC team helped review batch records provided by the Chinese manufacturer for test kits used in testing required for FDA submissions and conducted an audit of the manufacturer’s facilities to ensure quality and regulatory compliance.
Manufacturing Oversight
Rook's APAC team audited overseas manufacturing facilities to identify and close quality gaps.
The APAC team also managed batch record reviews and final lot inspections before product release and ensured every product shipment met stringent FDA quality expectations.
The Results: Delivering Reliable, Lab-Quality Testing to Patients Nationwide
Today, Watmind USA stands as a testament to the power of strong quality and regulatory foundations. With over five million test kits distributed and a 0.0001% complaint rate, the company’s products have earned praise from families, healthcare workers, and regulatory professionals alike.
5+ million test kits distributed with a 0.0001% complaint rate
FDA-authorized, lab-quality diagnostic testing accessible to families nationwide
Trusted by healthcare professionals, caregivers, and regulatory authorities
And behind that success stands Rook, a dedicated partner, leader, and driver of compliance excellence.
Ready to Turn Quality into Your Competitive Advantage?
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