2San Global Achieves ISO 13485 Certification
2San, a prominent distributor of innovative Home Diagnostic Testing products, is thrilled to announce its achievement of Certification to ISO 13485:2016. This certification represents a significant milestone, as it is the globally recognized standard for Quality Management Systems specific to the medical device sector.
Commitment to Quality and Compliance
The accomplishment of ISO 13485 certification reflects 2San's unwavering dedication to excellence in meeting the rigorous requirements set forth by the FDA and other regulatory bodies worldwide. This certification underlines the organization’s commitment to delivering high-quality products that are safe and effective.
Feedback from the Leadership Team
Dan Calder, co-Managing Director of 2San, expressed pride in the efforts of the Quality and Regulatory team. He stated, "Our Quality and Regulatory team have done exceptional work in preparation for, and in completing the robust process audits of our organization." This commitment to quality resonates throughout the entire company.
Significant Achievements
Moreover, Ralph Webb, Global Commercial Director, shared, "We are excited to have completed this significant milestone, 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." This achievement paves the way for future growth and innovation.
Elevating Standards in Home Diagnostics
According to Chelsea Tooze, Global Director of Quality & Regulatory, the ISO13485 certification ensures compliance with the highest standards of industry expectations around the globe. She emphasized that this will enable 2San to elevate and innovate its offerings, establishing effective controls that focus on the efficacy and safety of medical devices supplied globally.
About 2San
2San is a transformative global diagnostics company dedicated to reshaping the future of healthcare through innovative home-testing diagnostic solutions. The company is committed to making good health accessible to everyone, believing that self-testing is a crucial pathway toward this goal. By understanding their health, individuals can choose more informed treatment options, leading to improved outcomes. 2San strives to empower people to take control of their health and wellness at their convenience, emphasizing the mantra: Better care, Better life.
Frequently Asked Questions
What does ISO 13485 certification mean for 2San?
ISO 13485 certification indicates that 2San meets international standards for quality management systems in the medical device industry, ensuring safety and efficacy.
How does this certification impact customers?
This certification enhances customer trust, assuring them that the products they receive comply with the highest safety and quality standards.
What is the mission of 2San?
2San's mission is to deliver innovative self-testing products that empower individuals to manage their health effectively and conveniently.
Who are the key leaders at 2San?
Key leaders include Dan Calder, co-Managing Director, Ralph Webb, Global Commercial Director, and Chelsea Tooze, Global Director of Quality & Regulatory.
How does 2San plan to grow its product offerings?
With the ISO certification, 2San aims to expand its self-test portfolio, ensuring higher standards of quality and innovation in their offerings.
