NanoDx | Point-of-Care Diagnostics

Our Mission

At NanoDx, we are committed to revolutionizing healthcare by leveraging our nano-biosensor platform technology to develop innovative, cost-effective diagnostic solutions designed to help people worldwide live healthier, safer, and happier lives. We strive to be a global leader in point-of-care diagnostics, empowering healthcare professionals, advancing clinical research and innovation, promoting health and wellness, expanding patient access, and reducing the cost of healthcare.

Our Our Commitment to Quality

At NanoDx, our Culture of Quality is the cornerstone of our dedication to promoting the consistent and predictable delivery of our brand promise. By upholding the principles below, we ensure that our products are not only safe and effective but also trustworthy and sustainable, making a positive impact on health and wellness. This commitment extends to our suppliers, who play a vital role in our company’s overall success and the reliability of our products. This Quality Policy will be reviewed annually to ensure its ongoing relevance and alignment with our goals.

Customer-Centric Innovation

We are committed to developing products and solutions that meet the evolving needs of our patients, healthcare providers, and clinical researchers. Our innovation is grounded in a deep understanding of the challenges faced by the healthcare industry and the unmet needs of our customers. We are focused on creating products and solutions that advance diagnostic capabilities, not only in our own rapid application development, but also serve as research tools in the life sciences and healthcare community.

Integrity and Transparency

At NanoDx, we operate with the utmost integrity in all our interactions, whether with customers, partners, investors, or each other. We prioritize open, honest communication and uphold the highest ethical standards. This transparency builds trust with our stakeholders and ensures accountability at all levels of the organization. We pledge to consistently meet the requirements set forth by federal and state authorities and other relevant international regulatory agencies. Our commitment to Compliance ensures the safety, reliability, and efficacy of our medical devices.

Continuous Quality Improvement

We are relentless in our pursuit of excellence. NanoDx is dedicated to continuous improvement in all areas of our business. We maintain a robust quality management system focused on:

Evolving Quality Beyond Compliance: Compliance ensures we meet standards – doing things right, but true quality goes further – ensuring we do the right things for our patients, stakeholders, and the business.

Enhancing Patient Safety and Efficacy: Our risk management and quality control and assurance processes are designed to protect and enhance patient outcomes and ensure product efficacy.

Driving Corrective and Preventive Action (CAPA): CAPA is central to identifying, addressing, and preventing potential issues that could impact product quality and patient safety.

Strengthening Supplier Quality: All suppliers are subject to rigorous qualification processes, including supplier quality agreements that outline compliance expectations with current regulations and standards. Ongoing evaluations, including annual audits and performance reviews, ensure that supplier quality meets NanoDx’s high standards for safety and effectiveness.

Maintaining Alignment with Corporate Strategic Goals and Objectives: We communicate quality goals clearly across the organization, ensuring that quality initiatives align with broader corporate strategies and objectives and, in concert, not conflict, with speed, cost, and value.

Promoting Consistency and Standardization: We foster standardization across the organization while promoting a cross- functional, enterprise-wide approach to improvements.

Improving Efficiency and Reducing Costs: By working towards higher process maturity levels and reducing variability, we enhance efficiency while maintaining quality.

Measuring and Communicating Quality Performance: We monitor key performance indicators (KPIs) and critical-to-quality (CTQ) measures at both the enterprise and functional levels and regularly review them through Management Reviews.

Collaboration and Education

We believe in the power of collaboration and are committed to working closely with healthcare professionals, regulatory bodies, industry associations, and scientific and medical communities. Through open communication and continuous learning, we aim to not only advance our own knowledge and the professional development of our employees but also contribute to the broader healthcare community’s understanding of diagnostic innovations.

Team Empowerment

We recognize that our employees are the foundation of our success, and that Quality is everyone’s responsibility. At NanoDx, we foster an inclusive work environment that:

Encourages open communication regarding quality concerns.

Values individual contributions and their impact on success.

Promotes the sharing and implementation of ideas to continuously improve processes and procedures.

Encourages and promotes professional development and growth.

Honors diverse backgrounds and experiences, ensuring all voices are heard and considered.

By empowering our team, we strengthen our ability to deliver exceptional value to our customers and make meaningful contributions to healthcare.

144 Turnpike Road Suite 110
Southborough, MA 01772
info@nanodiagnostics.com
(508) 599-2400
LinkedIn

*The NanoDx™ System has not been evaluated by the FDA or other regulatory agencies.

Our Mission

Our Our Commitment to Quality

Customer-Centric Innovation

Integrity and Transparency

Continuous Quality Improvement

Collaboration and Education

Team Empowerment

Sustainability and Environmental Responsibility

Learn More About the NanoDx™ System

Our Mission

Our Our Commitment to Quality

Customer-Centric Innovation

Integrity and Transparency

Continuous Quality Improvement

Collaboration and Education

Team Empowerment

Sustainability and Environmental Responsibility

Learn More About the NanoDx™ System

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