Medical Device Testing
Medical Devices
As reliability and safety are fundamental requirements for medical devices, RJ Lee Group is a trusted partner in product development and quality assurance. From raw materials selection to wear analysis, our materials scientists and chemists deliver the utmost assurance on product performance and patient safety.
We provide critical support for customers who are developing new medical devices, from research and development to customer feedback, market approval, and regulatory compliance. Our medical device clients rely on our materials expertise and laboratory support whether developing the next generation of insulin pumps or evaluating the effectiveness of new sutures.
The health and safety of people around the world depends on a rigorous medical device testing and development process, and that's why top manufacturers rely on RJ Lee Group.
Our Approach
RJ Lee Group approaches the medical device industry with meticulous attention to detail and an unwavering commitment to quality. Our team's expertise in materials science and engineering ensures that every analysis meets the highest standards, directly contributing to the safety and efficacy of your medical devices.
Key Services
- Wear Debris Analysis
- Failure Analysis
- Biocompatibility Testing
- Mechanical and Chemical Characterization
- Regulatory Compliance and FDA 510(k) Clearance/Pre-Market Approval Support
What Sets Us Apart
Our laboratory's cutting-edge technology, combined with our team's comprehensive expertise, enables us to offer unparalleled support in the development and testing of medical devices. From prototype to production, we ensure every device meets the industry's rigorous standards.
Testing Services
Materials Characterization
Failure Analysis
Investigating device failures to identify root causes and recommended improvements.
Wear Debris
Utilizing advanced techniques for debris analysis in wear testing to evaluate the long-term performance and safety of implantable devices.
Cleanliness and Contamination Control
How We Support Our Clients
Comprehensive Material Analysis
Our laboratory utilizes a range of analytical techniques to understand the properties and performance of materials used in medical devices, ensuring they meet strict regulatory and performance requirements.
Debris Analysis
We specialize in the analysis of wear debris in medical implants, providing critical insights into the performance and longevity of devices.
Regulatory Compliance Support
Assisting clients with FDA submittals and regulatory compliance, ensuring that devices are safe and effective for patient use.