We're committed to delivering the critical information you need for your regulatory submission
You’ll get the personalized attention and support you deserve when you partner with Element. We treat your goals as our own - and together, we'll evaluate risk and ensure compliance with comprehensive ISO 10993-18 chemical characterization, also referred to as extractables and leachables (E&L) studies for medical devices. Throughout our partnership, you can expect:
- • Extensive E&L databases
- • A deep understanding of materials and chemicals with extensive unknown identification knowledge
- • In-depth medical device and pharmaceutical experience
- • Lean scheduling to provide additional capacity and address urgent needs
- • Dedicated support from subject matter experts at the forefront of the evolving regulatory landscape
Explore a partnership with Element
Let us know what you're looking for - click the orange "Get more information" button and fill out a short form. A member of our team will be in touch with you. Keep scrolling to learn more about our global network of labs, and scroll further down to know more about how we'll help you bring safe devices to patients around the world with comprehensive ISO 10993-18 testing.
Standard and customized material characterization studies
You'll be supported by more than 75 chemists committed to safety, quality, and best-in-class service. Our labs in North America and the UK are:
• Equipped with a large range of equipment and redundancy
• FDA and/or Health Canada inspected
• Offer toxicological assessments
• Hold or are pursuing ISO 17025 accreditation
Let us know how we can help you meet regulations
If you're interested in connecting with our team, click the orange "Start the conversation" button and fill out a short form. Looking for more information? Keep scrolling to learn more about how we can help you achieve regulatory approval and comply with regulations.
Helping you obtain regulatory approval and clearance
As a true partner, we're invested in your success. We'll help you obtain regulatory approval and clearance with the most efficient, risk-based protocols for the chemical characterization of materials as required by ISO 10993 for regulatory filings.
Our experts carry out comprehensive chemical characterization of medical device materials and deliver the data you need - along with scientific justification - in time for regulatory submissions. Together, we'll ensure patient safety and increase speed to market.
Demonstrate a risk-based approach to ISO 10993
We'll help you meet best practices and industry regulations with the most efficient, risk-based chemical characterization testing protocols. You'll get the data you need for your regulatory submission when you leverage our decades of experience testing medical device materials to ISO 10993-18 guidance for chemical characterization.
Get to know Element
Ready to navigate the most efficient path to regulatory approval with Element? Just fill out our form to request more information. Scroll down to explore a handful of our many services to help you achieve navigate the most efficient path to market and quickly obtain approval and clearance.
Your global testing and certification partner from R&D to market
Still researching? Here are a handful of our many services to help achieve regulatory clearance and approval quickly and efficiently.
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.
Medical Device Wear Testing
Typical devices that Element performs wear testing on include Hip Prostheses, Total Knee Replacements, Spinal Device, and Small Bone or Join Replacements.
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.
Microbiological Analysis
Element provides a wide range of microbiological analysis projects for medical devices, from pathogen and bioburden testing to endotoxin and cytotoxicity analyses.
EMC Testing for Medical Devices
Find out how Element works with manufacturers of electrical medical devices to identify the testing, and certification needed for compliance to EMC safety standards and international regulations.
Medical Device Battery Testing
Element ensures the integrity of your products in both home and professional healthcare settings as well as their compliance with international regulations.
CE Marking and Testing
CE marking is a mandatory conformity mark enabling you to enjoy free movement between all 28 Member states.