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Medical Device Analysis Services From Gateway Analytical

We're experts in foreign particulate analysis and wear debris testing, which are among the most important experiments conducted during the rigorous testing of medical devices. Plus, we can help you to identify the conditions that led to the emergence of defects or the failure of a product.

Medical Device Analysis Process Infographic

Our material characterization services help explore and measure the physical, mechanical, chemical, and microstructural properties of your sample materials.

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The primary goal of our analysis is to afford you the scientific understanding necessary to resolve critical production issues. You can apply the material characterization services from Gateway Analytical to several critical areas, including:

  • Research and Development – to conduct primary research and test new materials and concepts
  • Process Development – to try new processes, tools and designs
  • Process Improvement – to monitor process performance and the resulting process changes
  • Production – qualify materials that come in, as well as monitor materials for quality control
  • Failure analysis – investigate problems through defect evaluation, contamination analysis and conducting informed material comparisons
  • Reverse Engineering and De-formulation

You may have already identified the material of interest, but you require further information regarding specific properties such as interface sharpness, morphology, the depth distribution of a particular element, stress, crystal structure, thickness, or quality.

In other cases, you may not have identified the component or material of interest, and you need information about its composition and identity. The material characterization protocol we employ at Gateway Analytical covers a wide range of analyses and tests, including mechanical tests, performance tests, trace analysis, surface analysis, and composition analysis. 

We know that materials and components are becoming increasingly complex. The techniques and methodology used to characterize and analyze them, in turn, have to be progressively sophisticated. Gateway Analytical has one of the most advanced analytical laboratory facilities available for the evaluation of organic and inorganic materials and compounds. 

Our materials scientists work with the latest material innovations, applying advanced characterization techniques guided by investigation requirements. Their experience working with different methodologies and materials ensures that we deliver an accurate interpretation of the resulting data. Proper interpretation leads to a well-informed comprehension of the nano, micro, and macro-scale properties and their interactions within the sample materials. 

Generally, we select the series of characterization techniques we employ for a specific inquiry based on the information you need and the form of the material samples. Most of the standard characterization techniques focus on the analysis of solid samples, although liquid sampling are also possible. Some of the material characterization techniques we employ include:

Fourier-transform Infrared Spectroscopy 

FTIR is used to acquire the infrared spectrum (molecular fingerprint) of emission or absorption of gas, solid, or liquid. FTIR spectrometer obtains high-spectral-resolution data over a broad spectral range. Gateway Analytical uses a large sample compartment-style spectrometer, FTIR microscopes, coupled with Attenuated Total Reflectance.

Energy Dispersive X-ray Spectroscopy (EDS)

Energy Dispersive X-ray spectroscopy is used for the chemical characterization or elemental analysis of a material sample. It relies on the interaction between a material sample and a source of X-ray excitation. 

The characterization abilities of EDS result from the principle that every element bears a unique atomic structure that allows a unique peak set on their electromagnetic emission spectrum (the fundamental principle behind spectroscopy). We couple our EDS capability with our Scanning Electron Microscopy services.

SEM, or scanning electron microscopy is a powerful and useful method for visualizing the microscopic details of a sample. SEM is versatile for determining the composition of samples based on image contrast by atomic number, or investigating the topography of materials simply by switching detectors. Coupling SEM with an energy-dispersive X-ray (EDS or EDX) detector, one can also determine the elemental composition of materials and understand the relative abundance of these elements. SEM-EDS is a useful tool for providing high-resolution imaging coupled with elemental composition to gain a greater insight into a materials chemical structure and content.

Raman Spectroscopy

Raman spectroscopy uses laser technology to analyze the rotational and vibrational modes of molecules. This characterization technique provides a molecular fingerprint (Raman spectrum) that enables the examination of the material crystalline structure as well as the identification of organic and inorganic materials.

Microscopy

Our set of microscopy techniques probe and detail the sub-surface and surface structure of a material. They utilize electrons, ions, photons, or physical cantilever probes to obtain material sample structural data on a range of length scales. Some of the microscopy techniques we use include stereomicroscopy, polarized light microscopy, fluorescence microscopy, and comparison microscopy, among others.

At Gateway Analytical, we discuss the results of our material characterization analysis with all our clientele to provide an intelligible understanding of how it affects their products. We also offer advice on a plan of action for process control, quality assurance, and product improvement.