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Spectral MD Holdings, Ltd (“Spectral MD” or the “Company”) Completion of ISO 13485 Certification Audit
ISO 13485 Certification Recommended and Anticipated in Q3 2023 LONDON & DALLAS--(BUSINESS WIRE)-- Spectral MD Holdings, Ltd. (AIM: SMD), an artificial
About this update from Spectral Ai, Inc.
[{"type":"text","content":"\nISO 13485 Certification Recommended and Anticipated in Q3 2023\n\n\n LONDON & DALLAS--(BUSINESS WIRE)--\nSpectral MD Holdings, Ltd. (AIM: SMD), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, announces it has completed the quality management ISO 13485 certification audit for the manufacture and distribution of its DeepView® Wound Imaging System. ISO 13485 certification has now been recommended and is anticipated in Q3 2023. 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.\n\n\nISO 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. The comprehensive audit of the Company’s quality management system was undertaken by an Independent Registrar.\n\n\nNiko Pagoulatos, Chief Operating Officer of Spectral MD, 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.”\n\n\nAbout Spectral MD\n\n\nSpectral MD is a predictive AI company focused on medical diagnostics for faster and more accurate treatment decisions in wound care for burn, DFU, and future clinical applications. At Spectral MD, we are a dedicated team of forward-thinkers striving to revolutionize the management of wound care by “Seeing the Unknown”® with our DeepView® Wound Diagnostics System. The Company’s DeepView® platform is a predictive diagnostic device that offers clinicians an objective and immediate assessment of a wound’s healing potential prior to treatment or other medical intervention. With algorithm-driven results that have a goal of substantially exceeding the current standard of care in the future, Spectral MD’s diagnostic platform is expected to provide faster...