Medical Device Testing Services
Medical Device Testing Services
 

About Us

Quality

Medical Device Testing Services is A2LA Accredited (Testing Cert#2783.01). In order to obtain this accreditation, A2LA performs a thorough, bi-annual audit of our laboratory and testing services to the requirements of ISO 17025. ISO 17025 accreditation is not the same as ISO 17025 compliance, which indicates only that a laboratory claims to be in compliance with the ISO 17025 requirements and is not obligated to undergo a regulatory audit.

ISO 17025 accreditation is also more demanding than Good Lab Practice (GLP). Although there are similarities in general quality procedures, the practices required by an ISO 17025 accreditation are more demanding than GLP, and provide greater security in accuracy of data and results.

In addition to our accredited tests, MDT performs a wide range of custom tests. These tests include tension/compression, torsion/rotation, and bending. All tests are created using the same Quality Management system. We maintain a full-time quality manager on staff. We welcome questions or input with respect to our quality policy and will provide associated documentation upon request. MDT customers are invited to complete our customer survey to provide feedback on our services.

A2LA Scope:

Test Method Test Standard
In Vitro Pulsatile Durability Testing of Vascular Stents
ASTM F2477
ISO 25539-1, Annex D
ISO 7198, Annex A
In vitro axial, Bending, and Torsional Durability Testing of Vascular Stents
ASTM F2942

Cardiovascular implants and extracorporeal system — Vascular prostheses — Tubular vascular grafts and vascular patches

Circumferential tensile strength
Longitudinal tensile strength
Kink diameter radius
Dynamic radial compliance

ISO 7198, Annex A
Medical Device Testing  

Hip Devices

Hip Stem Static and Dynamic

 

ISO 7206 -4, -6

Knee Devices

Cyclic Fatigue Testing of Metal Tibial Tray

Components of Total Knee Joint Replacements

 

 

ASTM F1800

Spinal Devices

Spinal Implant Constructs

Intervertebral Body Fusion Devices

Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model

 

ASTM F1717

ASTM F2077


ASTM F2706

Other Medical Devices & Related Materials

Metallic Bone Plates Single Cycle Bend Testing Determining the Bending Fatigue Properties

Dynamic Fatigue Test for Endosseous Dental Implants

 

ASTM F382, Annex A1 and A2

ISO 14801

 

 

Medical Device Testing Services Quality