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.

Medical Device Testing

Standards We Test To

Hip Device

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

Knee Device

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

Spinal Device

ASTM F1717, ASTM F1798, ASTM F2077, ASTM F2193, ASTM F2267, ASTM F2346, ASTM F2423, ASTM F2624, ASTM F2706

ISO 18192

Dental Implant

ISO 14801

Trauma Device

ASTM F382, ASTM F384, ASTM F543, ASTM F564, ASTM F1264, ASTM F1541, ASTM F2193

Extremity Device

ASTM F1357, ASTM F1378, ASTM F1829, ASTM F2028, ASTM F2665 

Microbiological

ISO 10993-5, ISO 10993-12, ISO 11135, ISO 11737-1

USP 61, USP 62, USP 85, USP 87

Package Testing 

3-A Sanitary Dairy Testing (No. 18 & 20) 

6-FEDEX-A, 6-FEDEX-B 

6-SAMSCLUB

6-AMAZON.COM

ASTM D3228, ASTM D4169, ASTM D6551 

FED-STD-101C 

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 

Porous Coating

ASTM F1044, ASTM F1147, ASTM F1160, ASTM F1854, ASTM F1978 

Miscellaneous 

ASTM F1089, ASTM F2183

Orthopedic Device Testing 640 x 480
Featured Service

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.

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featured Service

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-Therapeutic Equipment 640 x 480
Featured Service

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. 

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featured Service

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. 

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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.

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Our team of nearly 2,000 Engaged Experts working across the USA, Europe and Asia are ready to support you. How could we help you today?

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