Medical Device Testing Services is ISO/IEC 17025:2005 certified; A2LA Accredited Testing Cert#2783.0. Consistently meeting, if not exceeding, your expectations is a requirement. Our commitment and dedication to quality is asserted in our Quality Policy Mission Statement:
"Medical Device Testing Services, Inc. is dedicated to meeting or exceeding customer expectations by providing technical assistance and on-time delivery of the best quality services available in the medical device testing industry. Our customers are our most important business partners, we will adapt to their changing needs at all times in an environment of continuous improvement. We will be an industry leader through continuous improvement, teamwork, technical expertise and innovation in all of our business practices."
In addition to our accredited tests, MDT performs a wide range of custom tests. These tests are created using the same Quality Management system. We welcome questions or input with respect to our quality policy, and provide associated documentation upon request.
A2LA Scope:
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Test Method
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Test Standard
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In Vitro Pulsatile Durability Testing of Vascular Stents
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ASTM F2477-07*
ISO 25539-1-Amendment 1
ISO 7198:1998
99128
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In Vitro Curved Pulsatile Durability Testing of Vascular Stents
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99132
ASTM F2477-07*
ISO 25539-1-Amendment 1
ISO 7198:1998
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In Vitro Simulated Gait motion for intravascular devices
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99134
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In Vitro Simulated Tension/Compression for intrarvascular devices
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99134
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In Vitro Simulated Torsion/Rotation for intravascular devices
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99134
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In Vitro Simulated Bending for intravascular devices
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99134
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Determination of circumferential tensile strength
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ISO 7198:1998; 8.3.1
ISO 25539-1-Amendment 1; E.5.3.9
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Determination of longitudinal strength
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ISO 7198:1998; 8.3.2
ISO 25539-1-Amendment 1; E.5.3.12
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Determination of suture retention strength
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ISO 7198:1998; 8.8
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Determination of kink Diameter/radius
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ISO 7198:1998; 8.9
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Determination of dynamic compliance
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ISO 7198:1998; 8.10
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Crush Resistance
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ISO 25539-1-Amendment 1; E.5.3.10
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Migration Resistance
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ISO 25539-1-Amendment 1; E.5.3.13
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Pull Test for Modular Components
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ISO 25539-1-Amendment 1; E.5.3.14
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Strength of Stent attachment to system to graft
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ISO 25539-1-Amendment 1; E.5.3.17
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Compression
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ISO 25539-1-Amendment 1; E.5.3.11
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* Other Methods Used Per Customer Specifications
