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.
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
Orthopedic and Spine Device Testing
Element is a globally recognized leader in orthopedic device testing for manufacturers across the industry. We have years of experience testing and evaluating hip implants, knee prostheses and spinal devices. Our high-capacity laboratory runs a wide variety of orthopedic device testing services, allowing us to accelerate time to market for manufacturers.
Cardiovascular Device Testing
Element specializes in a wide range of cardiovascular device testing, such as stents, grafts, occluders, vena cava filters, heart valves and pacemaker leads. Services include pulsatile fatigue, torsion durability, strength characterization testing, mechanical bending and in vitro simulated gait motion for peripheral devices.
Implantable, Diagnostic and Therapeutic Equipment Testing
Element performs electromagnetic compatibility (EMC), safety, and operational tests for a variety of medical devices and components, including implantable devices, diagnostic tools and therapeutic equipment.
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.
Ready to request a quote?
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
Learn more about our laboratories - where they are located; the unique capabilities they have and how they can help you solve your technical and commercial challenges.
Discover perspectives, resources and advice from our world-leading Engaged Experts.
Maciej has over 10 years of experience in medical device testing and analysis for FDA 510(k) and CE submissions.
Kent is the co-founder of Medical Device Testing Services, acquired by Element in 2017. Kent’s expertise in medical device testing has led to the development of new test instruments, standards and protocols.