#USA #Boston #ISO 13485 #2San #Home Diagnostics

2San Global Achieves ISO 13485 Certification

2San, recognized as a frontrunner in the field of home diagnostic testing, has recently made headlines by announcing its achievement of the prestigious ISO 13485 certification. This certification is internationally acknowledged as a benchmark for quality management systems specifically tailored to the medical device sector.

With this significant milestone, 2San underscores its dedication to maintaining high-quality standards while adhering to regulatory requirements established by the FDA and other international authorities. The achievement of ISO 13485 showcases the company's relentless pursuit of excellence in developing innovative home testing solutions designed to empower individuals with actionable health information.

Significance of ISO 13485 Certification

Dan Calder, co-Managing Director at 2San, highlighted the exceptional efforts of the Quality and Regulatory team in meeting the rigorous demands of the certification process. The successful completion of extensive auditing processes reflects the organization's commitment to conformity to the highest standards expected in the medical device industry.

Calder stated, "Achievement of ISO 13485 demonstrates our compliance with industry standards globally. It is crucial for establishing trust with our customers and partners, further solidifying our position as a reliable player in the healthcare space."

Empowering Health Management

2San's mission revolves around delivering high-quality, user-friendly self-testing products that allow individuals to manage their health and wellness conveniently. Ralph Webb, Global Commercial Director, expressed excitement about the certification, stating, "This significant accomplishment is not only a source of pride for our team but also assures our customers that we are committed to the utmost quality in our self-testing portfolio."

The emphasis on self-testing solutions caters to a growing consumer demand for accessible healthcare. By enabling people to perform tests in the comfort of their own homes, 2San aims to foster a proactive approach to health management. This shift encourages individuals to take charge of their health by providing them with valuable insights into their well-being.

Continuous Improvement in Offerings

Global Director of Quality & Regulatory, Chelsea Tooze, acknowledged that attaining ISO 13485 certification will further elevate 2San’s product offerings. She stated, "Achieving this standard not only allows us to meet compliance requirements but also serves as a foundation for innovation as we place emphasis on the efficacy and safety of our medical devices distributed worldwide."

2San is evolving the landscape of healthcare by making diagnostic solutions not only available but also intuitive and reliable for everyday use. The certification encapsulates the brand's focus on continuous improvement and effectiveness in delivering quality home diagnostic tools.

About 2San

Founded with the ambition to revolutionize healthcare, 2San is a global diagnostics company dedicated to providing innovative home-testing solutions. The company believes that health should be a universal right and champions the cause of self-testing as a pathway to better health outcomes.

As they continue to expand their self-test portfolio, 2San remains committed to providing the tools necessary for individuals to make informed decisions about their health.

To learn more about their products and initiatives, visit 2San’s official website.