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

Particle sizing, counting, and identification analysis provides a detailed accounting of foreign particulate matter present on or within a medical device.

Particulate Sizing, Counting & Identification

The presence of foreign materials in pharmaceutical products and medical devices can impact the immediate and long-term safety of the product. However, these foreign particles are often below the size range that can be manually manipulated. Gateway Analytical utilizes specialized sample preparation techniques to collect foreign particulates from drug products and automated, high throughput techniques to accurately determine elemental, spectral, and morphological information.

Our particle sizing, counting, and identification services allow our customers to analyze large populations of particles down to submicron scales within a matter of hours. This automated service can be performed on organic, inorganic, and metallic materials.

More specifically, our experts use SPE-Raman to count and size particles as small as 2 microns, while automated SEM-EDS can find particles down to the submicron level. All data reported in size bins as requested by the customer. Additionally, we have the ability to build customer-specific reference databases to fast track sourcing and root cause analysis services.

Reach out to our technical experts and tell us how Gateway Analytical can deliver value for your R&D project.