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 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 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 testingproduct qualification, 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.

Medical device testing

Industries We Serve

  • Orthopedics and Spine
  • Ancillary
  • Cardiovascular
  • Pharmaceutical
  • Implantable, diagnostic, and therapeutic equipment

Our Services

Element offers the most comprehensive range of product qualification testing services for the medical device sector.

Orthopedic Device Testing 640 x 480
Services

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.

Read More
Cardiovascular Device Testing 640x480
Services

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.

Read More
Services

EMC 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.

Read More
Microbiological Analysis 640x480
Services

Microbiological Analysis

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

Read More
Medical Device Battery Testing 640x480
Services

Battery Testing

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

Read More
Accelerated Aging Shelf Life Testing 640x480
Services

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.

Read More
IEC 60601 Medical Device Safety Testing 640x480
Services

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.

Read More
Services

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.

Read More
Cta_Small_1600x480

Our team of over 6,700 Engaged Experts in North America, Europe, The Middle East, Australia, Asia and Africa are ready to help you.