Adds Analytical Testing to Current Capabilities to Expand Value Proposition in Global Medical Device Market Segment
Northbrook, IL / Ochsenhausen, Germany – August 2, 2011 – UL, a world leader in advancing safety, today 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 9001 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. This includes orthopedic, ophthalmic, and many cardiovascular implantable devices.
"The deepening of our service offerings will put the UL brand in front of a wider variety of customers – including some of the biggest companies in the medical and health field," said Anil Patel, General Manager of UL Health Sciences. "From sterile gauze and bandages to more complex devices such as bone screws, contact lenses, orthopedic, dental and other implantable devices, UL’s testing capabilities will help manufacturers develop products that will keep patients healthy and mobile."
"MDT and UL share the vision of providing comprehensive clinical and non-clinical 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 lifecycle."
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.
Founded in 1988, MDT is a privately-owned leading provider of clinical and non-clinical testing services for medical device manufacturers. With approximately 40 employees, its headquarters are located in Ochsenhausen, Germany. MDT is EN ISO/IEC 17025 accredited as a test laboratory and as a medical clinical research organization (CRO) for medical devices by the Central Authority of the Länder for Health Protection (Central Authority). MDT is also GLP certified as a test facility for non-clinical services. Additional information can be found at www.mdt-gmbh.com.
Founded in 2005 in Ochsenhausen, Germany, md registration support Ltd. provides hands-on assistance for medical device manufacturers to comply with global regulations and requirements to obtain CE-marking of their devices. It helps clients prepare technical documentation, build quality management systems, establish risk management processes and to prepare clinical evaluations and biocompatibility assessments. MDRS is EN ISO 9001 and 13485 certified to help start-up companies develop, establish and maintain regulatory registrations. Additional information can be found at www.mdrs-ltd.com.
UL is a premier global independent safety science company with more than 116 years of history. Employing more than 6,900 professionals in over 100 countries, UL has five distinct business units — Product Safety, Environment, Life and Health, University, and Verification Services – to meet the expanding needs of our customers and to deliver on our public safety mission. Additional information about UL may be found at UL.com.