BrainCool AB – unannounced audit performed by the notifed body TÜV SÜD, without any major deviations
The German notified body, TÜV SÜD, has performed an unannounced audit of the company´s certified medical product and quality management system, with a focus on production and delivery processes. The outcome of the audit was positive, with no major deviations. The European Commission expects all Notified Bodies to perform unannounced audits as a post-market surveillance measure to ensure CE-marked medical devices meet approved safety and performance requirements and specifications from raw materials to finished goods at all times. Unannounced audits are performed at least once every