Medical devices, and especially implants, require an outstanding quality which can only be achieved by controlled processes and continuous inspections and measurements.

MeKo performes a 100 % final visual inspection of all components for implants (stents, heart valves, clips, …) in order to ensure highest quality.

  • More than 120 stereo microscopes (Olympus, Zeiss, Leica, Vision Engineering)
  • More than 100 special high-end inspection microscopes
    • measurements with an accuracy of 1 µm
  • Stent scanners developed in-house
  • Automated measuring systems
  • Confocal laser scanning microscope
  • Tensile testing
  • Radial strength testing of stents
  • Cross section and grain analysis
  • Surface roughness
  • Scanning Electron Microscopes (SEM)
  • Energy Dispersive X-ray Spectroscopy (EDS) surface analysis
  • Bend and Free Recovery (BFR)
  • Differential Scanning Calorimeter (DSC)
  • Electrochemical Impedance Spectroscopy (EIS)
  • Potentiodynamic tests
  • Degradation Test Lab (DTM)
  • Atomic Force Microscope (AFM)
  • ...

Special trained inspectors operate the instruments. MeKo provides ergonomic work places to improve inspectors’ concentration.

MeKo Quality Inspection

Through the use of automatic microscopes hundreds of measurements can be taken on a single work piece.

The results of these measurements ensure our customers the highest level of measurement confidence possible.

BFR Test Diagram

The Bend and Free Recovery (BFR) method is applied for measuring the active Af temperature of NiTi devices.

  • Accurate method for all geometries → no limitations for sensitive parts
  • Self-developed in-house and optimized for accurate measurements
  • Non-destructive method for verifying the real transformation behavior
  • Computer-assisted, fully automatic temperature cycling
  • Printed graph including the Af temperature determined

Please see also DSC below

Grain Size of Stent-Material

We take cross sections of devices to analyze grain structures, heat affected zones of laser welds, ...

Degradation Test Lab

MeKo performs in-vitro degradation tests for magnesium scaffolds:

  • simulated blood circulation
  • controlled flow rate, pressure, pulsation and temperature of circulation
  • blood substitute solution for standardized tests: PBS, SBF, ...
  • accelerated in-vitro degradation tests
    •    fast and reproducible evaluation of degradation
    •    monitoring and visualization of degradation process
    •    prediction of in-vivo degradation behavior

Informations about bioresorbable implants

DSC Test Diagram

Utilizing DSC, MeKo determines the transformation temperatures (Af temperatures) of shape memory alloys like NiTi (Nitinol).

  • Precise measurement of the transformation temperatures by use of representative samples.
  • Results can be linked to BFR (Bend and Free Recovery) measurements.
  • A DSC graph - including the evaluation of the Af temperature of the heat treated parts will be sent along with the medical devices.
EDX Test Diagram

With our EDS system, material compositions and surface contaminations are analyzed.

EIS Test Diagram

The EIS is typically applied to measure the AC-current and AC potential.

In corrosion testing, EIS is standard practice for measuring the polarization resistance (Rp) of corroding systems.

Stent 316 LVM polished

Using Scanning Electron Microscopes (SEM), MeKo investigates devices with high resolution and a magnification up to 30,000x.

Corrosion Tests

With potentiodynamic measurements the passivation and corrosion resistance of products are analysed in accordance with ASTM F2129.

Roughness Test Equipment

We analyze surface roughness using a variety of testing methods, including contact stylus profilometry and confocal laser scanning microscopy.

Tensile Test Chart

At MeKo, we know how to change the mechanical properties of implant materials by means of heat treatment.

To document the results, MeKo does not only check the time-temperature-curves of each heat treatment but also verifies the results by tensile tests.

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