Medical Device Analysis
Successful medical devices encompass robust safety, durability, and lifetime. Our medical device analysis services support both development and post-market study.
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.
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.
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Frequently Asked Questions:
Gateway Analytical continues to stay up to date on the latest methodology for medical device analysis to ensure customers are compliant with current ISO specifications and requirements. Gateway Analytical is alerted with any potential change to the methods, and all trained analysts are required to perform analyses in accordance to the update.
Gateway Analytical performs all analyses for medical devices in an ISO Class 5 laminar flow hood with all essential PPE to ensure optimal cleanliness and safety during the sample handling process.
When determining study design, Gateway Analytical follows relevant ISO procedures dependent on the submitted device. Gateway Analytical’s team of expert scientists assists customers in developing configurable test methods to meet their needs.
Although Gateway Analytical does not provide time points when performance should be evaluated in medical devices, the team of experts are always at the customer’s disposal for any guidance relevant to their device.
All analyses at Gateway Analytical yields beneficial information to the customer about their specific device in regards to regulations needs and risk factors. Gateway Analytical has helped customers determine malfunction within a lot of devices and assist customers in characterizing unwanted particulate to support source determination.