ESi's medical device experts have the ability to undertake a wide variety of complex medical device, surgical & medical instrument, and biomaterial projects. Regardless of whether the device is used in the body, on the body, or near the body, ESi has the ability to form a multidisciplinary team to address all relevant engineering and regulatory issues.
ESi has experience with assisting medical device manufacturers with new product design, product evaluations and performance, and FDA submissions, as well as manufacturing support and troubleshooting. As part of FDA regulatory compliance, ESi can assist clients with developing a design and regulatory strategy, a pre-clinical testing plan, and conduct design and manufacturing validations. ESi can also assist medical device manufacturers with equipment procurement, installation qualifications, operational qualifications, process qualifications, and quality control issues.
Additionally, ESi’s engineers have experience with manufacturing, failure analysis, medical device explant (retrieval) analysis, materials and product testing, recall management, product liability technical support, and engineering consultation.
ESi's expertise spans dozens of industries and specializations organized across several practice groups, each staffed by dozens of in-house experts with the technical knowledge, hands-on expertise, and courtroom experience required to execute projects for and with our clients from start to finish.Find an Expert Contact Us