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) testing, CE marking, and other medical device regulatory submissions. Our turnkey invasive and non-invasive physiological monitoring studies apply to the entire product lifecycle, from R&D to validation for regulatory submission.
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, clinical validation 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.
Contact us today to learn how Element can provide testing services and consultation for your medical device.
Our Medical Device 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.
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 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.
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.
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.
Extractables and Leachables Studies
Element's extractables and leachables studies offer tailored solutions that ensure patient safety and compliance with industry standards.
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.
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.
With extensive experience evaluating prefilled syringes and autoinjector components for functionality and integrity, Element can help you successfully navigate regulatory requirements for testing.
ISO 18562: Biocompatibility Analysis
Element provides ISO 18562 biocompatibility analysis for respiratory and ventilation devices to support global device approval.