Successful medical devices encompass robust safety, durability, and lifetime. Our medical device analysis services support both development and post-market study.

Medical Device Analysis Process Infographic

Understanding where our services are desired and made most effective is our #1 priority. Download our Medical Device Analysis Process Poster today to learn more.
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Hip replacements. Orthopedic pins. Infusion pumps. At Gateway Analytical we understand there isn’t any room for error when it comes to quality-of-life-enhancing medical devices. Our FDA-inspected laboratories are equipped with the analytical instrumentation required to conduct rigorous pre-market and post-market analysis and testing, from particulate identification to wear debris testing to failure analysis.

Whether your company is developing a novel coating designed to limit particle shedding or considering changes in raw materials suppliers, it’s important to identify modes of failure and avoid costly missteps before they happen. When failure occurs or inquiries are made, it’s equally important to quickly and accurately assess the problem and create solutions.

We’re a team of experts with a track record of creating value and delivering success in the medical devices industry.
Contact us to learn how Gateway Analytical can help you produce results for your next project.

Our medical device analysis services provide answers to your team’s unique technical and regulatory challenges.

Medical devices cover a wide range of applications and functions, and can be evaluated on diverse criteria. Gateway Analytical can help you to achieve successful outcomes without letting complexity stand in your way.

Wear Debris Analysis
Wear Debris Analysis

Identify the lifetime, modes of failure, and appropriate lubricants for your medical device.

Infusion Equipment Analysis
Infusion Equipment Analysis

We can collect, size, and count foreign particulates present in inner fluid pathways.

Failure & Defect Analysis
Failure & Defect Analysis

Avoid costly fractures and surface corrosion to improve product and patient safety.

Particulate Sizing, Counting & Identification
Particulate Sizing, Counting & Identification

Quantify particulate matter on or within your medical device early in the development process.

S Materials Char
Materials Characterization

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 conceptsProcess Development – to try new processes, tools

Antonio Scatena
Senior Sales Representative

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