NORTHBROOK -- UL has acquired MDT medical device testing GmbH and MD registration support Ltd., both based in Ochsenhausen, Germany.
They will become part of UL's Life and Health business unit.
MDT is a leading accredited and GLP certified test laboratory for the medical services industry. MDT specializes in clinical and nonclinical testing services for regulatory and routine control purposes. Its testing services include clinical investigations as a clinical research organization and comprehensive nonclinical testing services such as physicochemical and chemical analyses, physical testing, mechanical testing, biocompatibility testing, microbiological and virological testing, cytotoxicity testing and validation of cleaning, reprocessing, sterilization and packaging processes.
MDRS's advisory services enable customers to meet comprehensive medical device registration requirements through technical documentation, risk assessment, clinical evaluation, evaluation of biocompatibility, classification of medical devices and quality management assessments.
UL will now offer a complete suite of services that will help medical device manufacturers produce safer devices and products, including key medical device testing. The addition of MDT and MDRS will further support UL on a global scale to help medical device manufacturers obtain required medical device certification.
In an effort to meet the growing demands of the medical device market, the acquisition gives UL best-in-class global capabilities that will be offered to both its current customer base, and more notably, to a larger segment of medical device manufacturers, that perform critical health functions in the human body. This includes orthopedic, ophthalmic, and many cardiovascular implantable devices.
"MDT and UL share the vision of providing comprehensive clinical and nonclinical services, with the sole purpose of supporting manufacturers provide safe and effective medical devices to patients around the globe," said Dr. Dieter R. Dannhorn, CEO and president, MDT and MDRS. "Together, we can provide a full spectrum of testing and consulting services necessary to help medical device companies develop and manufacture innovative medical devices and document safety and effectiveness of these products throughout the product's life cycle."
MDT and MDRS will become part of UL's Life and Health business unit. MDT and MDRS will continue to be headquartered in Ochsenhausen, Germany. Dr. Dieter R. Dannhorn will remain with the companies and serve as the General Manager.
About mdt medical device testing GmbH (MDT)