AI Medical Technology announces its quality management system is now ISO 13485:2016 certified by BSI under the certificate number MD762240.
This indicates that AI Medical Technology’s quality management system conforms to the recognized international standard for the design, manufacture and distribution of medical devices.
The certification also demonstrates that AI Medical Technologies’ quality management system is aligned with EU regulations which will support commercialization of its Dermalyser AI-driven decision support tool when CE marking is achieved.
“We are delighted to reach this next stage in our journey to provide dermatologists and physician with an accurate and reliable decision support tool to ensure rapid and accurate melanoma diagnosis,” says AI Medical Technology’s CEO Christoffer Ekström.
“Currently we are receiving extremely promising feedback from our ongoing multi-center, prospective, non-interventional study involving 37 Swedish primary care facilities. As well as evaluating the clinical performance and user friendliness of Dermalyser, this will significantly build our image library – with over 100,000 skin lesion images by far the biggest in the sector – our AI learns from. Our aim is to complete the trial by the end of the year,” he adds.