Neurolens Achieves ISO 13485 Certification

Neurolens Achieves ISO 13485 Certification

Reinforcing Commitment to Medical Device Quality and Innovation

Neurolens, a leader in innovative optometric device technology, is proud to announce that it has achieved ISO 13485:2016 certification, marking a significant milestone in its commitment to delivering safe, high-quality medical devices. This certification reinforces Neurolens’ dedication to excellence in the design, manufacturing, and distribution of advanced solutions for binocular vision issues, including its groundbreaking N3 device.

ISO 13485 is the internationally recognized standard for quality management systems in medical devices, ensuring compliance with the highest industry regulations. This certification validates Neurolens’ rigorous processes and unwavering commitment to safety, effectiveness, and continuous improvement.

“The achievement of ISO 13485 certification is a testament to our team’s dedication to quality and innovation,” said Gregory Boisse, SVP R&D, Operations, & Compliance. “This milestone reflects our dedication to excellence in the design, development, and manufacturing of innovative solutions like the N3 device.” The N3 offers an immersive, virtual reality-based experience that educates patients while providing objective, accurate, and repeatable measurements of binocular alignment. “This certification not only enhances our credibility but also assures our partners and patients of our adherence to the highest international standards.”

At the core of Neurolens' innovation is the N3 device, a virtual reality-based diagnostic tool that provides objective, repeatable measurements of binocular alignment while also educating patients on the impact of eye misalignment. By combining cutting-edge technology with precision engineering, Neurolens continues to transform patient care and enhance clinical outcomes.

Neurolens extends a special thank you to Dana Duncan, Director of Quality and Compliance, and the entire Neurolens team for their exceptional efforts in achieving this certification. The company also acknowledges the Intertek Business Assurance team for their partnership throughout this process.

For more information on Neurolens and its innovative solutions, visit www.neurolens.com

About ISO 13485

ISO 13485 is an internationally recognized quality management system standard specifically designed for medical device manufacturers. It ensures that organizations meet regulatory, safety, and customer requirements in the design, development, production, and distribution of medical devices. Achieving ISO 13485 certification demonstrates an organization’s commitment to consistently delivering safe and effective medical products.

About Intertek

Intertek is a leading Total Quality Assurance provider that specializes in testing, inspection, and certification for various industries, including healthcare and medical devices. With a global network of experts, Intertek helps businesses ensure regulatory compliance, improve product quality, and enhance market credibility. Their ISO certification services support companies in achieving and maintaining internationally recognized standards.