We offers wide rang of laboratory services for medical device testing.

Mechanical forces testing:

  • Film tensile strength

The thin film is pulled until it breaks in order to measure elongation, tensile modulus, tensile yield strength, and tensile strength at break.

  • Compression test

By applying pressure on various materials or components to measure the breaking point.

  • 4 point and 3-point bending

Bend testing is performed in order to measure yield point and flexural strength on all types of product and materials.

  • Sutures mechanical properties:

    • Knot pull (U.S.P)

      Knot pull is tested by creating a knot in the middle of the test area and pull until reaching breaking point

    • Suture tensile strength

      Suture tensile strength test is a key element in determine the sutures required material.

    • Needle Pullout test

      This destructive test is to evaluate the required tension force to break the needle.

 

 

Biodegradable implants tests:

  • Degradation Profile Tests

The degradation behavior of every bio-degradable material has a pattern that can be measured in order to better understand implementation period and the processes that the material is going through when it contacts body fluid.

  • Moisture analysis.

    This test is used to determine the water content of a materials. The sample is being dried to a constant mass at pre-defined temperature.

  • Erosion test

    This test examines erosion profile of biodegradable components, sutures weight loss during a total time period.

  • This test examines the number of cycles needed to raise the coefficient of friction.

 

Coating tests:

  • Coefficient of friction.

    This test examines the number of cycles needed to raise the coefficient of friction.

  • Coating integrity.

    This test examines the layers of the coating and whether it has missing spots.

  • Adhesion test for coating or catheter connecting point.

    This test examines the forces connecting between the substrate and the coating.

 

General testing:

  • Extractable study.

    This study’s purpose is to screen and monitor presence of toxic materials according to FDA regulations.

  • Shelf life acceleration.

    The test is performed with elevated temperature and specific Humid conditions to predict product shelf-life at typical storage conditions.

  • Viscosity Measurement.

    The viscosity of a fluid is a measure of its resistance to gradual deformation by shear stress or tensile stress.

 

Packaging Validation:

  • Peel test

    This test is to examine the force needed to open the package seal, which can compromise the product sterilization.

  • Dye leak test

    This test determines the integrity of the package seal and reassures that there are no channels that leak in the pouch seal.

  • Humidity test

    When dealing with biodegradable products humidity test of the package is essential for the product desired shelf life.

  • Burst test

    This test determines package strength by pressurizing air into the package until it bursts.