Medical Device Testing Services
Medical Device Testing Services
 

Cardiovascular Devices

Cardiovascular Device Testing 

The field of cardiovascular device design has undergone rapid change with the introduction of many new devices. When the first stents were introduced MDT was there to provide new testing instruments and methodologies to support this emerging industry. Over the years MDT has tested a wide variety of cardiovascular devices including stents, grafts, occluders and vena cava filters. Our experienced staff is able to assist you with all aspects of your test program including test design, feasibility, protocol development and test performance. Using our Series 9000 Stent/Graft Testers and latest generation axial test instruments MDT has established itself as a world leader in cardiovascular medical device testing.

Tests that MDT has performed on Cardiovascular devices according to ISO 25539-1 (incl. amendment), ISO 7198: 2016 and other standards include:

 

Test Definition & Protocol Development

While FDA, ASTM, CE, and ISO standards are available, test protocols to meet these standards may need to be modified for your new design.  In these cases, or when no established protocols are available, MDT Services works closely with you in an iterative process to ensure tests are appropriate and generate meaningful data.

Product Feasibility & Device Evaluation

Quick feedback on new concept designs enables our customers to move rapidly from the product design stage to IDE. Our test engineers often create customized grips and fixturing for fast test setup and perform feasibility studies. As your design advances and requires accelerated durability testing, our engineers will ensure that the test equipment is configured and ready to meet your critical schedules.

Accelerated Durability

MDT Services has a wide array of fatigue testing capabilities including a full inventory of intravascular testing instruments. Featuring latest generation designs, our equipment incorporates computer control and data collection for accuracy, precision, and reliability. With decades of experience in fatigue tester design, our engineering staff can also build customized instruments and test fixturing for your more challenging applications.

Data Generation and Reporting

Experienced personnel, well designed protocols, and precision instruments produce reliable results. To ensure data integrity, our rigorous quality program requires duplicate data recording and management reviewed test reports. Our quality program has received top ratings by independent auditors. 

 

Cardiovascular Devices