Element Minneapolis - Minnetonka, formerly Medical Device Testing Services, is an ISO/IEC 17025 accredited laboratory that provides a broad range of testing services including Cardiovascular, Peripheral, Neurovascular, Dental, and Orthopedic Device Mechanical Testing, Corrosion Testing, and Particulate Counting and Analysis.
Since the group’s formation in 1990, our staff of highly-trained engineers and quality managers have consistently met the most demanding test requirements of the medical device industry (FDA, CE, ASTM, and ISO guidelines).
A true innovator in the medical device testing sector, Element Minneapolis - Minnetonka invented the linear motor-driven fatigue system which ushered in a new era of durability testing.
Lab Capabilities Sheet
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Minneapolis-Minnetonka Services
Cardiovascular Device Testing
Element specializes in a wide range of testing for cardiovascular devices, such as stents, grafts, occluders, catheters, heart valves and pacemaker leads.
Electrochemical Corrosion Testing
Element performs electrochemical corrosion testing per ASTM F2129 to ensure that medical devices are safe, and provided the intended benefits to the patient.
Pulsatile Durability Testing
Designed to demonstrate the long-term integrity of devices under mechanical fatigue, pulsatile durability typically simulates ten years of post-implantation use under accelerated conditions.
Neurostimulator Lead Testing
Neurostimulator lead testing subjects devices to flex fatigue and distal tip buckling, representing a minimum of 10 years post-implantation service life. Learn more from our experts.
Approvals, accreditations and documents
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Minnetonka A2LA Mechanical Scope and Certificate
PDF - 164.12 KB View
More from Element
Element Acquires Medical Device Testing Services
Element has announced that it has entered into an asset purchase agreement with Medical Device Testing Services (MDT), a specialist provider in Mechanical Testing and Materials Characterization for medical devices in the USA.
Medical Device Testing
As a comprehensive testing partner, you’ll enjoy the benefit of a single supplier source for all of your testing needs, from mechanical testing and environmental simulation to EMC and wireless device testing.
Medical Device Testing Experts
Our Engaged Experts are experienced in every stage of medical device testing - from test protocol development and prototype/feasibility trials to testing for 510(k), CE, and other regulatory submissions
Resources
Discover blog posts, articles, white papers, webinars, and advice from our world-leading testing, inspection, and certification experts.
