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, from small, start-up ventures to large, established manufacturers. Element supports every stage of medical device testing - from test protocol development and prototype/feasibility trials to testing and consultation for 510(k) testing, CE marking, and other medical device regulatory submissions. Our turnkey invasive and non-invasive physiological monitoring studies apply to the entire product lifecycle, from R&D to validation for regulatory submission. Partner with our experienced analytical laboratory team for Extractables and Leachables testing to identify harmful impurities and eliminate potential risk to medical device users. Together, we'll ensure regulatory compliance through a risk-based approach to extractables and leachables studies including ISO 10993 Biological Evaluation and ISO 18562 Biocompatibility Evaluation.