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.
Element supports every stage of medical device testing - from test protocol development and prototype/feasibility trials to testing and consultation for 510(k), CE marking, and other regulatory submissions.
Full product life cycle approach to medical device testing methods
As a comprehensive medical device testing partner, you’ll enjoy the benefit of a single source supplier for all of your testing needs, from feasibility and R&D to product development and production quality control. We offer a full suite of medical device testing, including mechanical testing, product testing, material characterization and microbiological evaluation.
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.
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.
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.
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.
Reusable Medical Device Validation
Our medical device experts evaluate the environmental impact on the identification markings and function of reusable medical instruments after repeated autoclave sterilization cycles.
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.
Element provides a wide range of microbiological analysis projects for medical devices, from pathogen and bioburden testing to endotoxin and cytotoxicity analyses.
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.
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.
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.
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.
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.
Test Protocol for Medical Devices
A protocol and plan will mitigate your risk, prevent confusion, set clear expectations, and preserve the necessary information for future reference and use.
Medical Device Testing Tips
Preparing for a medical device testing program can be a challenge for many manufacturers, especially if it is a new or novel product or if time is limited. Our medical device experts share their testing tips and best practices.
Discover blog posts, articles, white papers, webinars, and advice from our world-leading testing, inspection, and certification experts.
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.
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