Testing Service Category: Medical Device

Chemical Characterization

Understanding Chemical Characterization Testing The purpose of this testing is to determine a baseline to the extractable amount of chemical compounds present in and on a medical device and utilize extraction conditions similar to those utilized in biocompatibility determination of similar devices. Chemical Characterization Techniques Gas Chromatography/Mass Spectrometry (GC/MS): Analyzes the extract samples for Volatile […]

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Biocompatibility Testing

Understanding Biocompatibility Biocompatibility refers to the properties of materials being biologically compatible by not eliciting local or systemic responses from a living system or tissue. From a regulatory stance, biocompatibility is a series of tests that are used to determine the potential toxicity resulting from contact of the components of medical devices or combination products […]

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Analytical Chemistry

Understanding Analytical Chemistry Assessing the properties of a product, whether it is an unknown material or raw materials, is crucial when it comes to developing or quality- auditing a product. To help ensure product quality, consistency and safety, we offer a comprehensive range of analytical chemistry testing services. Analytical Chemistry Services Method development and validation […]

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Accelerated Aging Testing

Understand Accelerated Aging Testing The components used in the creation of medical devices and pharmaceuticals will change over time; this passage of time will have an effect on component materials, as can excursions in specified storage conditions, such as temperature and humidity. Understanding when and how changes occur to these products, especially changes that affect [...] Full Story