Quality System Certifications Awarded to NuraLogix

NuraLogix has achieved ISO 13485:2016 and MDSAP certficiations, confirming its commitment to maintaining high standards for designing, developing,  manufacturing, and distributing Software as a Medical Device (SaMD).

The certifications’ scope specifically covers optical and camera-based, contactless technology for measuring physiological parameters intended to assist in monitoring and/or diagnosing cardiovascular and respiratory conditions. These innovations are designed for both clinical and home use environments and this certification is recognized internationally, while also conforming to further specification requirements in Australia, Brazil, Canada, Japan, and the United States.

NuraLogix’s software with its patented Transdermal Optical Imaging (TOI) technology uses conventional cameras, including those embedded in smartphones and mirrors, to extract vital signs such as heart rate, breathing rate, and blood pressure—all without the need for physical contact.

“This certification marks a significant milestone for NuraLogix and validates the team’s commitment to quality, safety, and regulatory excellence in the field of medical software,” NuraLogix CEO Marzio Pozzuoli said. “It reinforces trust in our technology and opens the door to broader adoption of our solutions across healthcare systems globally. This recognition represents more than compliance—it’s a testament to our vision of revolutionizing remote health monitoring. As the demand for non-invasive, accessible healthcare solutions grows, this certification strengthens our ability to deliver trusted, scalable tools that empower health professionals and individuals alike.”

ISO 13485:2016 is the globally accepted standard for quality management systems specific to medical devices. Achieving this certification demonstrates that NuraLogix adheres to rigorous processes for risk management, product development, and continuous improvement—critical for software applications classified as medical devices. Gaining this certification is expected to accelerate the NuraLogix’s pathway to additional regulatory clearances and expand partnerships with medical device manufacturers, telehealth providers, and digital health platforms.

NuraLogix created one of the world’s first contactless blood pressure measurement technologies. Its patented Transdermal Optical Imaging technology can measure more than 30 health and wellness parameters using a conventional video camera to extract facial blood flow information from the human face. This is demonstrated in the company’s Anura software.