Prolira’s DeltaScan, the first objective device for delirium detection & monitoring based on EEG, was already CE certified since March 2018.
The CE mark means that the device is safe and effective for the intended use. 
As of August 2019, Prolira’s Quality Management System is ISO 13485:2016 and Annex II certified. This is an important milestone for the company and a great accomplishment of the entire Prolira team.