NORTHBROOK, Ill. and OCHSENHAUSEN, Germany, Aug. 2, 2011
/PRNewswire/ — 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 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
documen
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