Element Materials Technology’s Minnetonka laboratory, formerly Medical Device Testing (MDT), has expanded its A2LA ISO 17025 scope by adding an additional seven test methods to its capabilities.
The new expanded scope will add up to 12 test frames to Element’s global leading implant testing capacity, resulting in decreased time to market for clients and ultimately improved quality of life for the patient. The test methods address product evaluation testing of hip, knee, spine, and trauma implants. These certifications add to the laboratory’s already impressive list of cardiovascular test methods.
Rick Sluiters, EVP Aerospace, Element, commented: ‘’We are delighted to add these services to our facility in Minnetonka and further expand our capacity to support our clients. The Minneapolis area is a growth hub for medical devices and Minnetonka’s proximity will supplement our leading medical capabilities in the area including medical packaging, environmental, and EMC testing.
The recent acquisition of Exova has propelled Element to become one of the world’s leading providers of testing, inspection and certification services to the international medical device sector. We now offer a broad set of capabilities in engineering, materials, microbiology and chemistry that provide our customers with one stop technology services for medical device development and testing.’’
Element Minnetonka is the largest cardiovascular, A2LA accredited, testing facility operating in the USA, with over $6 million invested in commercial fatigue and durability test systems, inspection instruments and test fixturing inventory. The laboratory specializes in pulsatile, axial, and bending fatigue on stents, catheters, and heart valves, as well as neurostimulation devices.