UL (Underwriters Laboratories), a world leader in advancing safety, announced today the expansion of the South Bend, Indiana analytical laboratory to offer non-clinical testing services for the medical device industry.
In order to receive regulatory approvals, manufacturers of medical devices and bio-pharmaceutical equipment must demonstrate that their products are safe when interacting with the human body. Depending upon the degree and duration of direct contact with a patient, medical devices must be tested to internationally accepted biocompatibility standards to assess potential biological hazards, chemical and physical properties and interactions with the human body.
Testing to other internationally accepted standards is also performed, such as: basic microbiological testing, virological testing; shelf life of devices and packages; and validation of cleaning, reprocessing and sterilization.
"The expansion of these non-clinical services in North America means that UL is able to support the full spectrum of accredited testing and certification requirements throughout the product development life cycle - from concept to post-market follow-up." said Martha Bonino, Manager of UL's Medical Device Testing services for North America.
In 2011, UL acquired the ISO/IEC 17025 accredited and GLP certified test house MDT (medical device testing GmbH) located in Ochsenhausen, Germany that has operated for over 18 years. MDT specializes in clinical and non-clinical testing services. Leveraging MDT's strength, expertise and innovation, UL was able to expand these services to North America.
Building upon over 20 years of experience in analytical testing, the expansion of our South Bend laboratory enables us to provide value-added test data to confirm both the performance and safety of medical devices.