20th Jun 2023 14:13
(Alliance News) - Spectral MD Holdings Ltd on Tuesday said it has completed the quality management ISO 13485 certification audit for the manufacture and distribution of its DeepView Wound Imaging System.
Spectral MD is a London-headquartered artificial intelligence company focused on medical diagnostics for wound care treatment. The DeepView platform is a predictive diagnostic device that offers clinicians an immediate assessment of a wound's healing potential prior to medical intervention.
Spectral MD said ISO 13485 certification has now been recommended and is anticipated in the third quarter of this year.
"The completion of the audit validates Spectral MD's commitment to meeting the highest standards of quality, reliability, and safety in the medical device industry," it added.
The company explained that ISO 13485 is an "internationally recognized quality standard that specifies requirements for a quality management system used by an organization demonstrating its ability to provide medical devices and related services that consistently meet strict customer and regulatory requirements."
It noted that the audit of the company's quality management system was undertaken by an independent registrar.
Chief Operating Officer Niko Pagoulatos said: "The completion of the ISO 13485 certification audit is a strong endorsement of the quality standards we set at Spectral MD. Once received, it will help us achieve our goal of maintaining compliance with US and global laws and regulations that govern the medical device industry. This is a vital certification as we continue our preparations to enter the commercial phase across DeepView's Burn and Diabetic Foot Ulcer indications."
Shares in Spectral MD were down 4.2% to 40.70 pence each in London on Tuesday afternoon.
By Sophie Rose; Alliance News reporter
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