Orthopaedic & Medical Device Testing Services
Medical device testing involves rigorous analysis of device safety and performance using a range of biological, chemical, and physical assessments.
At Lucideon we provide end-to-end testing solutions for a range of medical devices including orthopaedics, dental implants, tools and instruments, therapeutic devices, and more. Our partnership approach and testing services can support your device at the development stage, manufacturing stage, and everything in between.
Our medical device testing solutions
- 510(k) approvals
- Cleaning and sterilization method development and validation
- Failure analysis
- Regulatory strategy testing
- Biocompatibility testing
- Static and fatigue testing
- Wear testing and tribology
- Particulate analysis
- Bioburden and sterility testing
- Environmental monitoring
Lucideon's approach to medical device testing
Lucideon offers comprehensive solutions to support the testing and evaluation of medical devices, ensuring they meet the highest quality and safety standards. Our ISO 17025 and GMP-accredited laboratories are equipped to perform a wide range of tests, including chemical, physical, microstructural, microbiological, and surface analysis, providing reliable data to inform your decisions.
With expertise in working to the requirements of global regulatory bodies such as the FDA, EMA, and PMDA, we help you address the challenges of compliance with confidence. Whether you need support developing testing methods, validating mechanical properties, or assessing material performance, our specialists collaborate with you to deliver accurate and actionable results.
Why partner with Lucideon?
Lucideon's experts sit on technical steering committees for the ISO and ASTM, guaranteeing technical expertise and industry insight in a field where precision and compliance are paramount.
Our extensive experience with different regulatory bodies, coupled with our state-of-the-art testing capabilities, positions us as an ideal partner for navigating the complex requirements of medical device testing to ensure your device is ready for market.
If you're looking for product development or on-shelf product support, contact Lucideon for expert support and high-quality analytical testing that meets even the most demanding standards.
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White Papers
In this white paper we look at why the testing of implants is so important. Traditional test methods and their limitations are detailed and adverse event testing is discussed
In this white paper we review the key tribology & testing techniques available for orthopaedic implants
This white paper provides an introduction to the theory behind fatigue in general, and the factors that affect how materials perform in fatigue
This white paper offers additional guidance that could help support implant manufacturers in their decision-making and justifications for regulatory submissions
Wear simulation for implantable knee, hip and intervertebral spinal disc prostheses have all been well documented and standardised tests methods have been created to assess the performance of these medical device implants
This white paper highlights some of the testing involved in ISO 13356 and discusses how recent and ongoing research into ceramic processing provides opportunities to meet product improvement challenges
Case Studies
Characterization of the surface chemical composition of medical implants
Lucideon assists in identification and prevention of staining of orthopaedic instruments
Analysis of failed polymer components in orthopaedic instruments using a range of testing and analysis techniques
Surface contamination investigation carried out by Lucideon
Testing and analysis provided by Lucideon
Lucideon expertise helped a client with additive manufactured implants