Spectral AI, Inc., based in Dallas, has been at the forefront of MedTech innovation since 2009. The company is an artificial intelligence company focused on medical diagnostics for faster and more accurate treatment decisions in wound care. Their flagship product, the DeepView™ System, uses medical imaging combined with predictive AI to look forward in time to see if a burn wound will heal when presented on day-one. By leveraging their proprietary “Seeing the Unknown®” approach, Spectral AI provides clinicians with objective and immediate assessment of a wound so a clinician can make an appropriate treatment plan.
The DeepView™ System stands as a cutting-edge predictive diagnostic tool that assists healthcare providers, especially in burn centers and emergency departments (EDs), by quickly assessing the healing potential of burned tissue. This capability is crucial for determining the necessity of surgical interventions. The system uses advanced AI algorithms to identify areas of a wound that are unlikely to heal on their own and may require surgical intervention. DeepView® aims to expedite treatment decisions with the goal of improving patient outcomes and reducing healthcare costs.
The Situation
As Spectral AI advanced towards commercializing the DeepView™ System, they faced the need to upgrade their quality management system to meet regulatory compliance. Achieving ISO 13485 Certification was essential for market access and demonstrating readiness for securing funding from the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services.
A critical challenge emerged just two days before their internal audit when it was discovered that the scheduled Medical Device Single Audit Program (MDSAP) audit, essential for market readiness, could not proceed as planned. This unforeseen obstacle jeopardized their certification audit timeline.
The Solution
As a result of TMAC’s assistance, the Spectral quality team gained a deeper understanding and confidence in handling regulatory requirements. Processes were streamlined, stress was reduced, and audit preparation became more efficient.
TMAC’s rapid intervention proved invaluable, not only ensuring Spectral AI met their audit schedules but also providing comprehensive support across various processes. This included enhancing manufacturing quality control, data management, cybersecurity, and navigating regulatory pathways.
The Results
Spectral AI successfully completed the ISO 13485 Certification Audit with zero findings. The combination of passing the audit and demonstrating good compliance practices ensured the organization made strides to achieve the milestones defined by its government partner, BARDA, and gained confidence to receive funding.
Despite achieving zero findings during the certification audit, all five members of Spectral MD’s Quality Team also completed ISO 13485 training through TMAC. This commitment underscores the team’s dedication to maintaining the highest standards of quality excellence within Spectral MD.
“We are committed to continuous improvement and will keep engaging with services that foster and expedite this journey. The exceptional quality of support we received from TMAC has been invaluable, and we look forward to continuing our partnership with them in the future.”
– Maddie Ashiani, Director of Quality Assurance
