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, blue chip manufacturers.
Our Engaged Experts are experienced in every stage of medical device testing - from test protocol development and prototype/feasibility trials to testing for 510(k), CE, and other regulatory submissions.
As a comprehensive medical device testing partner, you’ll enjoy the benefit of a single supplier source for all of your testing needs, from mechanical testing and metallurgical analysis to material characterization and microbiological evaluation as well as EMC testing and Medical Device Directive safety testing.
Orthopeadic and Spine
Find out how Element helps orthopaedic hip implant, knee prostheses and spinal device manufacturers to get to market faster.
Find out how Element tests stents, grafts, occluders, vena cava filters, heart valves and pacemaker leads.
Element out how Element uses its EMC, safety, and operational tests to help make certain that the implants it tests are safe and fit for purpose.
Additional Medical Device Services
Element's expansive medical device testing capabilities also includes: electromagnetic compatibility testing, safety testing, wireless/radio testing, microbiological testing, package testing, and regulatory compliance services.
Standards We Test To
ASTM F1440, ASTM F1612, ASTM F1714, ASTM F1814, ASTM F1820, ASTM F1875, ASTM F2009, ASTM F2345, ASTM F2580, ASTM F2582
ISO 14242, ISO 7206-3, ISO 7206-4, ISO 7206-6, ISO 7206-8
ASTM F1223, ASTM F1672, ASTM F1800, ASTM F1854, ASTM F1978, ASTM F2083, ASTM F2777
ISO 14243-1, ISO 14243-2, ISO 14243-3, ISO 14879
ASTM F1717, ASTM F1798, ASTM F2077, ASTM F2193, ASTM F2267, ASTM F2346, ASTM F2423, ASTM F2624, ASTM F2706
ASTM F382, ASTM F384, ASTM F543, ASTM F564, ASTM F1264, ASTM F1541, ASTM F2193
ASTM F1357, ASTM F1378, ASTM F1829, ASTM F2028, ASTM F2665
ISO 10993-5, ISO 10993-12, ISO 11135, ISO 11737-1
USP 61, USP 62, USP 85, USP 87
3-A Sanitary Dairy Testing (No. 18 & 20)
ASTM D3228, ASTM D4169, ASTM D6551
ISTA 1A, ISTA 1B, ISTA 1C, ISTA 1D, ISTA 1E, ISTA 1G, ISTA 1H, ISTA 2A, ISTA 2B, ISTA 2C, ISTA 2D, ISTA 3A, ISTA 3B, ISTA 3C, ISTA 3D, ISTA 3E, ISTA 3F, ISTA 3G, ISTA 7D
ASTM F1044, ASTM F1147, ASTM F1160, ASTM F1854, ASTM F1978
ASTM F1089, ASTM F2183
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Our deliverable is certainty - high quality data, test reports and certificates that you can absolutely rely on when making decisions about your materials and compliance. Engage with an expert today.
More from Element
Early Stage qualification
Our regulatory affairs team incorporates Engaged Experts that have clinical expertise and who have performed regulatory affairs roles in other organizations making them ideally suited to providing the guidance and advice needed to get your product through the regulatory requirements as quickly and efficiently as possible.
As a comprehensive testing partner, you’ll enjoy the benefit of a single supplier source for all of your testing needs, from mechanical testing, environmental simulation to EMC and wireless device testing.
Element performs a wide variety of mechanical testing including fatigue testing of medical devices.
Discover perspectives, resources and advice from our world-leading Engaged Experts.