Medical Device Testing Services
Medical Device Testing Services
 

About Us

Company

Medical Device Testing Services

MDT is the largest A2LA accredited medical device testing company with over $6 million in commercial fatigue and durability test systems, inspection instruments, and test fixturing inventory. We invented the linear motor driven fatigue system which ushered in a new era of durability testing. Our customers have used our testing services and data in hundreds of successful submissions to the FDA, CE and other regulatory bodies.

Medical Device Testing Services

Since 1990, our staff of engineers and quality managers have been meeting the most demanding test requirements in the industry per FDA, CE, ASTM, and ISO guidelines. Medical Device Testing's (MDT) ISO 17025 accredited laboratory (cert. #2783.01) has over 50 Instron, Bose and MTS systems and a highly trained staff to help you design your test protocol. Our mission is to provide test design, execution, and documentation using a rigorous, certifiable quality program that helps our customers fast-track their submission to the FDA and to other regulatory agencies. We offer a full range of testing capabilities including fixturing design and silicone tubing to facilitate precision test setups. MDT has no affiliation with any university or device company.

Medical Device Testing Services

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Medical Device Testing Services (MDT) was founded in 1990 as a division of EnduraTEC Systems Corporation, which specialized in the development of novel material test instruments for the medical device community. In 2000, MDT was spun off as a separate company to provide greater focus on testing services. Throughout its 25 year history, the company has tested many new designs including stents, grafts, pacemaker leads, heart valves, vena cava filters, defibrillators, percutaneous heart valves, and many other devices. Under the leadership of Kent Vilendrer, Founder and CEO, MDT has been a world leader in the development of proprietary test instruments, controls, fixtures, standards and test protocols. Kent holds 6 patents in materials testing, bioreactor designs, fatigue test systems and test fixtures including the original patent 5,670,708 for the 9100 Series Stent Graft Testers as well as several patents pending. In 2004, the equipment manufacturing part of EnduraTEC was sold to Bose Corporation and the group was subsequently renamed the Bose ElectroForce Group (now part of TA Instruments). EnduraTEC’s contract testing business was retained and renamed to Medical Device Testing Services.

The company's state of the art 10,300 square foot facility in Minnetonka, MN (western suburb of the Twin Cities) boasts the largest inventory of advanced test systems in the country and is adept at configuring them to meet the customer’s specific test needs. The experienced staff and consultants have helped companies move hundreds of products through the FDA and other regulatory bodies' approval process. We have worked with small startups to many Fortune 500 companies over the years. Most of the company's sales are through word of mouth from satisfied customers and we like to say that our customers are our best salespeople. The company’s services include:

  • Test feasibility and design
  • Protocol development
  • Test implementation
  • Results recording and reporting
  • Data interpretation

The company develops new instrument, controls, and fixturing and engages in R&D projects on an ongoing basis. Many engineers on MDT's staff have been with us for ten years or more.

Medical Device Testing Services is A2LA Accredited (Testing Cert#2783.01). A2LA performs a thorough, biannual audit of our laboratory and testing services to the requirements of ISO 17025. We employ a permanent full-time Quality Manager to ensure on-going quality control. You are welcome to call for additional information or to obtain a current copy of our latest quality manual.

In addition to our accredited tests, MDT performs a wide range of custom tests. These tests usually include tension/compression, torsion, bending, pulsatile loading and more. All of our tests are created using the same Quality Management system.

We believe that long-term customer satisfaction is the key to our success. We are committed to providing value and are always looking for ways to improve our value proposition. As part of our quality program we conduct customer feedback surveys to solicit feedback for how we can improve our services. We take this customer input seriously. We know that you will find us to easy to work with, and we will strive to be an invaluable partner in your development programs.