Spectral MD has received certification to distribute and manufacture its DeepView wound imaging system, a device containing over 263 billion clinically-validated data points, which are used to help differentiate healthy and damaged tissue deep beneath the skin’s surface.

Using artificial intelligence (AI) technology for binary assessments of wound treatment, primarily focusing on burn and Diabetic Foot Ulcer (DFU) indications, DeepView is now ISO 13485 certified, an internationally recognised standard that signals the quality of medical device design, development and production.

Demonstrating the Quality Management Systems (QMS) consistency to meet rigorous customer and regulatory requirements, the achievement of certification follows an exhaustive audit of the company conducted earlier this year.

Niko Pagoulatos, chief operating officer of Spectral MD, said in a company statement: “The receipt of ISO 13485 confirms Spectral MD’s status as a global provider of medical devices that meet the highest standards of quality, reliability and safety.

“We believe that this acknowledgement reflects Spectral MD’s commitment to fostering a culture of continuous improvement, validates the robust sourcing and operational framework we have created, and provides an important competitive advantage as we continue our regulatory submission initiatives and advance towards product commercialization.”