BOSTON, Aug. 20, 2025 /PRNewswire/ -- 2San, a global distributor of innovative Home Diagnostic Testing products, is proud to announce that it has successfully achieved Certification to ISO 13485:2016, the premiere and internationally recognized standard for Quality Management Systems specific to the medical device industry.
The achievement of ISO 13485 demonstrates 2San's commitment to continued excellence, and alignment in meeting requirements for the FDA and other global regulators.
Dan Calder, 2San co-Managing Director, said,
"Our Quality and Regulatory team have done exceptional work in preparation for, and in completing the robust process audits of our organization."
This certification supports the mission of 2San to deliver innovative, easy to use, high quality, self-testing products that deliver actionable information and empower people everywhere to take control of their health where and when they choose.
"We are excited to have completed this significant milestone,"
shared Ralph Webb, Global Commercial Director,
"and we're confident that this substantial accomplishment will resonate with our customers and business partners as we continue to grow our self-test portfolio."
Global Director of Quality & Regulatory, Chelsea Tooze, shared,
"Achievement of ISO13485 for 2San ensures compliance to the highest standards of industry expectations globally."
This Certification will allow 2San to elevate and innovate our offerings to the next level while ensuring we are placing appropriate and effective controls which emphasize the efficacy and safety of the medical devices supplied across the world.
About 2San
2SAN is a global diagnostics company who are transforming the future of healthcare by delivering innovative home-testing diagnostic solutions that empower individuals to take control of their health and wellness where and when they choose. The company believes good health should be accessible to everyone, and self-testing for all is a key pathway to this end. Understanding your health leads to more informed treatment pathways and improved outcomes. Better care. Better life. Learn more about 2San at https://www.2san.com/