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 Marking, and other regulatory submissions.
Full 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 product qualification and mechanical testing to material characterization and microbiological evaluation.
Medical device testing solutions that you can trust
At Element, our dedicated team of experts have hundreds of years of experience in a wide range of testing services for Class, I, II and III medical devices to help you meet medical device 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 hipreplacements, knee prostheses, spinal devices & 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.
Implantable, Diagnostic & Therapeutic Equipment Testing
Element EMC, safety, and operational tests for a variety of medical devices and components, including implantable devices, diagnostic tools and therapeutic equipment.
Element provides a wide range of microbiological analysis projects for medical devices, from pathogen and bioburden testing to endotoxin and cytotoxicity analyses.
Accelerated Aging Shelf Life Testing
Our shelf life testing can help you determine how climatic & environmental factors like temperature, humidity, humidity and light 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.
Medical Device EMC Testing
Element is the ideal partner for EMC testing, safety, certification and global approvals of your Class I, II and III electronic medical devices.
IEC 60601 Medical Device Safety Testing
Element's medical device testing and certification services 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-contry and global approvals.
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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.
More from Element
High Speed Stent and Graft Testers
Our medical device manufacturing customers are regularly challenged with short timelines to bring products to market.
Our Cincinnati laboratory is Element's global Center of Technical Excellence for medical device testing.
Medical Device Testing Experts
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
Local laboratories, global platform
Doing business with one of our laboratories enables our clients' access to our global platform of expertise, capacity and capabilities.