The new European Medical Devices Regulation (EU-MDR) leads to changes in the classification of medical devices by risk classes. These changes mean a recertification of products for a large number of medical device manufacturers, which must be available by the end of the transition period on 26 May 2020. The necessary risk assessments, audits and documentation increasingly present major organizational and temporal challenges to manufacturers and consultative and auditing bodies.
CleanControlling Medical GmbH & Co. KG has adapted to the challenges and prepared itself with accredited testing procedures as well as the necessary testing capacities and the expansion of the laboratory infrastructure with around 500 m² of laboratory premises and with state-of-the-art equipment. The expansion and furnishing of the laboratory premises was already implemented and accredited in autumn 2018.
