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 three (3) years.
BrainCool recently received an updated EC certificate (MDD 93/42/EEC Annex 2) valid through 2024-05-26.
CEO Martin Waleij comments;
Yet another piece of evidence that BrainCool are in the forefront with the company’s quality management systems and that we are well prepared for any FDA audits of the company. For the US market, it is a practice that FDA Quality System Regulation (QSR) inspections occur on an unannounced, “surprise” basis.
We expect that unannounced audits will become more common as the new MDR Directive for the EU market enters into force.
For more information
Martin Waleij – CEO
+46 – 733 -93 70 76
E-mail: martin.waleij@braincool.se
About BrainCool AB (publ)
BrainCool AB (publ) is an innovative medical device company that develops, markets, and sells leading medical cooling systems for indications and areas with significant medical benefits within the healthcare sector. The company focuses on two business segments, Brain Cooling and Pain Management. BrainCool AB (publ) is based in Lund, Sweden, and its share is listed on Spotlight Stock Market.