Medical Device Analysis
Successful medical devices encompass robust safety, durability, and lifetime. Our medical device analysis services support both development and post-market study.
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.
Download Poster
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.
Frequently Asked Questions
How is Gateway Analytical keeping up with the latest technology for medical device analysis?
A:
How does Gateway Analytical guarantee safety among their samples?
A:
Which guidelines does Gateway Analytical use to determine study design?
A:
Does Gateway Analytical provide time points when performance should be evaluated in medical devices?
A:
Will the device analysis provide information on regulations needs and risk factors?
A:
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.
Identify the lifetime, modes of failure, and appropriate lubricants for your medical device.
We can collect, size, and count foreign particulates present in inner fluid pathways.
Avoid costly fractures and surface corrosion to improve product and patient safety.
Quantify particulate matter on or within your medical device early in the development process.
Identify the lifetime, modes of failure, and appropriate lubricants for your medical device.
Explore and measure the physical, mechanical, chemical, and microstructural properties of your sample materials.
