UL has acquired mdt medical device testing GmbH (MDT) and md registration support Ltd (MDRS). These two entities, based in Ochsenhausen, Germany, will become part of UL’s life and health business unit.
MDT is an accredited and GLP-certified test laboratory for the medical services industry, which specializes in clinical and non-clinical testing services for regulatory and routine control purposes. Its testing services include clinical investigations as a clinical research organization according to ISO 14155 and comprehensive non-clinical testing services such as physico-chemical and chemical analyses, physical testing, mechanical testing, biocompatibility testing, microbiological and virological testing, cytotoxicity testing and validation of cleaning, reprocessing, sterilization, and packaging processes.
With these acquisitions, UL will offer a complete suite of services that will help medical device manufacturers produce safer devices and products. The addition of MDT and MDRS will further support UL on a global scale to help medical device manufacturers obtain required medical device certification, including IEC 60601-X-X and ISO 10993-XX, as well as technical documentation services that enable medical device manufacturers to demonstrate product safety to regulatory authorities around the globe.
