CLS takes next step towards CE marking in neurosurgery by obtaining ISO certificate according to MDR and completion of study at Skåne University Hospital
Lund, Sweden – Clinical Laserthermia Systems AB (publ) (CLS or the "Company") today announces that the company has received ISO certificate in accordance with the new Medical Device Regulation (MDR) and that the follow-up of patients in the CLS-sponsored clinical study at Skåne University Hospital has now been completed. The company has thus achieved two very important milestones on the way to a market approval of the ClearPoint Prism® Neuro Laser Therapy System in Europe.CLS has obtained ISO certificate in accordance with MDR The change in the new Medical Device Regulation (MDR) places