Medical Device Analysis

medical device testing

Gateway Analytical is committed to providing analytical service solutions for medical device testing. We support the medical device industry in product development and lifecycle sustainability. We offer a combination of conventional and innovative techniques, following FDA, ASTM and ISO guidelines. Our multi-analytical approach allows us to provide in-depth data analysis for determining particle size distribution and characterization. We understand that you need results quickly. Our team works diligently to provide the fast, reliable reporting.

Wear Debris Analysis Testing Services (ASTM F1877)

Characterization of wear debris provides valuable information about the effectiveness of medical device design and the mechanics of wear. Particles released as wear debris from implants may result in an adverse biological response, which may affect the integrity of the device and could pose potential health risks to the patient. Gateway Analytical uses automated scanning electron microscopy and automated Raman spectroscopy to determine the size, morphology and chemistry of wear debris particles.

Particle Sizing and Counting (USP <788>)

An important factor in medical device testing is determining the size, shape and quantity of foreign particulates. USP <788> describes two methods for analyzing particulates in injections and parenteral infusions: light obscuration and microscopy. These two methods have been adopted by many medical device manufacturers to size and count particulates. Gateway offers Methods 1 and 2 for USP <788> testing.  Our expertise, along with clear and fast reporting, helps get your product to market faster.

Failure Analysis

Gateway Analytical provides failure analysis of medical devices using analytical testing methods such as microscopy, SEM/EDS, FTIR, and Raman spectroscopy. We are experienced in the analysis of polymers, adhesives, metals and coatings.

Contamination Analysis

Contamination analysis is critical to medical device development and manufacture. Our forensic scientists have over 20 years of experience sourcing particulate contamination.

Particle Sizing and Counting Using Chemical Imaging

Automated methods of analysis provide information about particle size, count, chemistry, morphology and distribution. Gateway Analytical provides Raman Chemical Imaging on medical devices to determine the size, count and distribution of API in polymers for stents and other drug-eluting devices.  Raman Chemical Imaging has also been utilized to evaluate layer thickness uniformity in stent products.

Contact Gateway today to learn more about how we can help you address your specific medical device analysis needs.

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