Spectral MD Holdings Ltd (AIM:SMD), the medical diagnostics company specialising in wound care, has achieved a significant milestone by successfully completing the ISO13485 certification audit for its DeepView wound imaging system.
ISO13485 is a widely recognised international quality standard for the manufacturing and distribution of medical devices.
Chief operating officer Niko Pagoulatos said: "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."
Spectral MD underwent a comprehensive audit of its quality management system, conducted by an Independent Registrar, to ensure compliance with the strict customer and regulatory requirements outlined in the standard.
The completion of the ISO 13485 certification audit reinforces Spectral MD's position as a trusted provider of cutting-edge medical diagnostics solutions, the company said. Formal sign-off is expected in the third quarter.