EAG scientists have years of experience investigating medical device failures, including fatigue resistance and hydrogen embrittlement. Metallographic examination of stents using optical or electron microscopy is a powerful tool for understanding the modes of medical device failures. EAG Laboratories has an unmatched ability to address all types of product failures, that may come to light at any stage of product development, including during testing.
From evaluating nickel biocompatibility per FDA August 2015 Guidance document, “Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems” to troubleshooting product failures, EAG Laboratories is your analytical partner. Many of our locations are ISO 17025-certified and/or FDA-registered.