UL expands presence in Medical Device Market

15 August 2011 - UL announced that it 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 a leading accredited and GLP certified test laboratory for the medical services industry.  MDT 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 (CRO) 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.  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 assessment pursuant to EN ISO 9011 and EN ISO 13485, respectively.

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 tests are conducted in laboratories that produce repeatable test results under and EN ISO/IEC 17205 and GLP/GCP quality management system, which will expose potential patient side effects well before the medical device is in the market.  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.

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.

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.

www.mdt-gmbh.com

www.mdrs-ltd.com.