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

Wear debris analysis determines the degree of particle shedding from a medical device and ensures your product remains in compliance.

Wear Debris Analysis

Much like the biological parts they replace or support, medical devices with two or more contact surfaces can deteriorate over time. The resulting wear debris particles can affect the life expectancy, quality, and safety of a product. Wear processes are inevitable. Whether you’re designing a prototype or responding to a regulatory inquiry, Gateway Analytical’s wear debris analysis service can help.

We use cutting edge microscopy, SEM-EDS, and Raman techniques to better understand wear processes and the wear debris particles generated from your product. These data are used to determine acceptable shedding limits, coatings, materials, and lubrication for your medical device and use case. Better yet, our experts have experience conducting wear debris analysis on a broad range of medical products, including implantable medical devices and drug inhalation devices.

Talk to us today about the unique project your team has in mind.