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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.

Attractive red-haired scientist looking through a microscope in a lab

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
Ascertaining the precise make-up of polymers, ceramics and metals.
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
Ensuring device cleanliness and identifying sources of contamination.
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.




Cutting-edge Biomedical Imaging Techniques
Sophisticated Material Characterization Tools
Advanced Computational Modeling for design optimization
State-of-the-art Wear and Fatigue Testing Equipment

Representative Clients

Medical Device Manufacturers
Biomedical Engineering Firms
Regulatory Compliance Agencies
Healthcare Providers

Client Success Stories

Implant XRay
Enhanced Device Durability through Advanced Material Selection.
Implant Materials
Identification and Resolution of Contamination Sources in Device Manufacturing.

Enhance Your Medical Device Testing with RJ Lee Group Experts

Learn more about how medical device testing can support your product development process from start to finish. Contact an RJ Lee Group expert today and schedule a time to review your needs.
Steve Schlaegle
William Koshut