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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, from small, start-up ventures to large, established manufacturers.


Our Full product life cycle approach to medical device testing

Element supports every stage of medical device testing - from test protocol development and prototype/feasibility trials to testing and consultation for: 

Our turnkey invasive and non-invasive physiological monitoring studies cover the entire product lifecycle, from R&D to validation for regulatory submission.


Medical device testing methods with Element 

We offer a full suite of medical device testing, including: 

As a comprehensive medical device testing partner, you’ll enjoy the benefit of a single source supplier for all  your testing needs, from feasibility and R&D to product development and production quality control. 


Medical device testing solutions that you can trust

Our dedicated team of experts have years of experience in a wide range of testing services for Class, I, II and III medical devices to help you meet regulations and ensure that every aspect of your medical device product is properly tested.

Contact us today to learn how Element can provide testing services and consultation for your medical device. 

Our Medical Device Services

Element offers the most comprehensive range of materials and product testing services for the medical device industry.

Orthopedic Device Testing 640 x 480

Orthopedic Implant Testing

As a global leader in orthopedic implant testing, Element has years of experience in evaluating hip replacements, knee prostheses, spinal devices and many other implants.

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Cardiovascular Device Testing

Element specializes in a wide range of testing for cardiovascular devices, such as stents, grafts, occluders, catheters, heart valves and pacemaker leads.

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EMC testing

EMI & EMC Testing

Element performs electromagnetic compatibility (EMC) and electromagnetic interference (EMI) testing for a variety of medical devices and components, including implantable devices, diagnostic tools and therapeutic equipment.

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Medical Device Reprocessing

Reusable Medical Device Reprocessing Validation and Testing

Every Reusable Medical Device must be reprocessed before reuse to minimize risk of contamination; this includes cleaning and either sterilization or disinfection.

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reusable medical device validation

Reusable Medical Device Life Cycle Validation

Our medical device experts evaluate the environmental impact on the identification markings and function of reusable medical instruments after repeated autoclave sterilization cycles.

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Automated Chemical Compatibility Testing

Chemical Compatibility Testing for Medical Devices, Materials, and Surfaces

Element can offer automated chemical compatibility testing that gives faster and more reliable results for medical device compatibility with medical disinfectants.

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Pharmaceutical Testing Extractables and Leachables

Extractables and Leachables Studies

Element's extractables and leachables studies offer tailored solutions that ensure patient safety and compliance with industry standards.

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Microbiological Analysis

Element provides a wide range of microbiological analysis projects for medical devices, from pathogen and bioburden testing to endotoxin and cytotoxicity analyses.

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Rated Burst Pressure & Leak Testing

Element specializes in performing rated burst pressure and leak testing for medical devices, including catheters, balloons, valves, medical bags, tubing, and connectors.

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Accelerated Aging Shelf Life Testing

Our shelf life testing can help you determine how climatic and environmental factors like humidity, temperature, and light will affect the lifespan and integrity of your products.

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Medical Device Battery Testing

Element provides safety and certification testing for rechargeable lithium-ion and nickel metal hydride batteries used in hospital and home health applications.

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IEC 60601 Safety Testing

Element provides provide a full suite of medical device testing and certification services to ensure that you meet the necessary IEC 60601 product safety requirements recognized across the world.

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Medical Device Regulatory Services

Our medical device regulatory experts help manufacturers of medical devices with product registrations, quality management systems, and in-country and global approvals.

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Connected Technologies - Medical

Clinical Validation Testing

Focus on growing your business with Element’s turn-key invasive and non-invasive physiological monitoring studies of medical devices and wearables.


Syringe Testing

With extensive experience evaluating prefilled syringes and autoinjector components for functionality and integrity, Element can help you successfully navigate regulatory requirements for testing.

IS0 18562-2

ISO 18562 Testing: Biocompatibility Analysis

Element provides ISO 18562 biocompatibility analysis for respiratory and ventilation devices to support global device approval.


Our team of over 9,000 Engaged Experts in North America, Europe, The Middle East, Australia, Asia and Africa are ready to help you.