PolarCool completes stage 1 of the MDR process and begins the final phase
PolarCool AB (publ), has successfully completed the first stage of the audit process for its own quality system ISO 13485 under the new MDR regulations. PolarCool develops and markets the PolarCap® System, a product that alleviates the effects of concussion injuries. PolarCap® is primarily used by sports organizations and facilities in contact sports such as ice hockey, rugby, football, and handball, as well as in sports with an increased risk of concussion. The audit, carried out with Intertek, a Notified Body (NB), involved an on-site evaluation of the company's quality system