NuraLogix Secures International Certifications for Contactless Medical Software Technology

NuraLogix, a Canada-based health technology company specializing in contactless health monitoring, has achieved key international certifications for its Software as a Medical Device (SaMD) offerings. The certifications include ISO 13485:2016 and Medical Software Device Accreditation Program (MSDAP) compliance, marking a significant step toward global regulatory alignment.

Certification Details

The certifications apply specifically to NuraLogix’s camera-based, optical technology designed to measure physiological parameters without physical contact. The software supports monitoring and diagnosis of cardiovascular and respiratory conditions and is intended for both clinical and at-home use.

These certifications are recognized internationally and conform to regulatory requirements across multiple countries, including Australia, Brazil, Canada, Japan, and the United States.

About the Technology

At the core of NuraLogix’s SaMD platform is its proprietary Transdermal Optical Imaging (TOI™) technology. TOI™ uses conventional video cameras — such as those embedded in smartphones, laptops, or smart mirrors — to analyze facial blood flow patterns. From this, it can extract vital signs such as:

1. Heart rate
2. Breathing rate
3. Blood pressure

This enables remote, contactless monitoring of over 30 health and wellness parameters.

Leadership Commentary

Marzio Pozzuoli, CEO of NuraLogix, highlighted the broader implications of the certification:

“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,” Pozzuoli said. “It reinforces trust in our technology and opens the door to broader adoption of our solutions across healthcare systems globally.”

He also noted the growing demand for non-invasive and accessible health tools:

“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.”

What ISO 13485:2016 Certification Means:

ISO 13485:2016 is the globally recognized standard for quality management systems in medical devices. Achieving this certification demonstrates that NuraLogix follows rigorous processes for:

1. Risk management
2. Product design and development
3. Quality assurance
4. Continuous improvement

Certification is expected to streamline NuraLogix’s pathway to additional regulatory clearances and support its efforts to partner with telehealth platforms, digital health companies, and medical device manufacturers.