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Bringing innovative medical device technology to the marketplace is a high‐risk venture. That’s why Element strives to provide absolute testing certainty by delivering accurate and reliable results for our clients’ medical device testing needs.
Our Engaged Experts have years of experience supporting medical device and contract manufacturers through each stage of medical device testing, from feasibility and R&D to product development and production quality control. Element offers a variety of testing services for medical devices, including mechanical testing, product qualification, and material characterization.
With years of experience testing endovascular devices, heart valves and pacemaker leads, our cardiovascular device testing programs are among the best in the industry. Our Engaged Experts assist with test design, product feasibility, protocol development and test inspections.The medical device... Read More
Element provides a wide variety of medical device testing services. Our engineering professionals are experienced in every stage of testing for medical device design and development - from test protocol development to prototype/feasibility trials to testing for 510(k) and other regulatory... Read More
Element is the solution to satisfy your compliance needs throughout the development cycle of your Class I, II, and III electronic medical devices.Our medical regulatory affairs experts work with manufacturers of electrical medical devices to identify the appropriate testing standards for your... Read More
We often get asked: “Do I need a test protocol?” or “How do I develop one?” This document outlines the common sections of a protocol. We highly recommend having test protocols in place prior to starting any study and will work with you to develop your testing strategy. Read more