3701 Port Union Rd.
Fairfield, OH 45014

About Element

Element is one of the world’s leading independent providers of materials and product qualification testing, inspection and certification services in advanced supply chains where failure in service is simply not an option.
We offer a full suite of medical device testing, including:

Mechanical Testing
Product Testing
Clinical Validation Testing
Wireless Device Testing
Material Characterization
Microbiological Evaluation

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.

Competitors of Element

Dynatek Labs Inc,

Dynatek Labs Inc. is a leader in medical device testing, providing cutting-edge solutions that ensure devices meet rigorous health standards. With over 35 years of expertise, our laboratory specializes in a variety of testing services, including heart valve testing, stent testing, and both acute... Read More

Machine Solutions Inc

Machine Solutions Inc. (MSI) is a global supplier of process and testing solutions to the medical device industry. Processing equipment includes stent crimping, stent loading, balloon pleating and folding, marker band swaging, catheter laser bonding, mandrel straightening, balloon forming, and... Read More


Since 1989, ADMET has been providing biomedical materials and device testing systems for tension, compression, bending, torsion and biaxial testing. ADMET systems are used in a diverse set of applications from testing from bone to metal, absorbable fiber based products to foam and elastomers. We... Read More

Products by Element

By Element

With years of experience testing endovascular devices, heart valves and pacemaker leads, our cardiovascular device testing programs are among the best in the industry. Our Engaged Experts assist with test design, product feasibility, protocol development and test inspections.The medical device... Read more »

By Element

Element provides a wide variety of medical device testing services. Our engineering professionals are experienced in every stage of testing for medical device design and development - from test protocol development to prototype/feasibility trials to testing for 510(k) and other regulatory... Read more »

By Element

Element is the solution to satisfy your compliance needs throughout the development cycle of your Class I, II, and III electronic medical devices.Our medical regulatory affairs experts work with manufacturers of electrical medical devices to identify the appropriate testing standards for your... Read more »

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Content by Element

Importance of Test Protocol for Medical Device Testing Projects

Importance of Test Protocol for Medical Device Testing Projects

Importance of Test Protocol for Medical Device Testing Projects

By Element

We often get asked: “Do I need a test protocol?” or “How do I develop one?” This document outlines the common sections of a protocol. We highly recommend having test protocols in place prior to starting any study and will work with you to develop your testing strategy.
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