Capabilities

We provide testing services to certify product and materials compliance, support quality control, and ensure the health and safety of workers and their environment. We provide assistance for clients who are not sure what tests they need. Our accredited materials characterization laboratory is the foundation of all the services of RJ Lee Group provides, including standardized testing for compliance, industrial hygiene and environmental analyses, quality control, and materials research and development.

We provide credentialed expertise supported built by robust scientific data. We provide significant support to industrial clients for product development, industrial hygiene and overall production support.

RJ Lee Group maintains a visible and respected reputation within the legal community, having offered scientific support in civil litigation matters for nearly 30 years. 

  • Product Liability 
  • Toxic Tort
  • Construction Defect
  • Fugitive Emission
  • Personal Injury
  • Patent Infringement
  • Contract Disputes
  • Insurance Subrogation

Subject Matter Experts

From our core business of providing scientific solutions to our clients, we have developed innovative products. Some are produced internally, and some have arisen from partnerships with other research organizations. 

For example, we build lab software solutions to help manage and streamline your labs data, and environmental testing products for a variety of applications. 

  • IntelliSEM is a powerful automated particle analysis system.
  • ParticleID is  a customizable cloud hosted web application used to identify foreign particulate matter and  assist with root cause investigations. 

Other products we create count particles and help keep the air and environment safe.

RJ Lee Group is a materials analysis laboratory and consulting company which serves many different industries. We offer scientific solutions such as industrial forensics services, laboratory and testing services, litigation support, and laboratory software to many industries:

Maintaining FDA Approval: Substitute Material

RJ Lee Group News

May 15, 2013

FDA approval is required for everything from bedpans to pacemakers. And although a splintered tongue depressor is generally not life threatening, deterioration of the surface coating of a stent can present a more serious problem. Regardless of the application, the materials used in the production process of a medical device are critical to the product’s performance and require FDA approval.

Our client successfully navigated the strenuous FDA-approval process to bring its medical device to market, but subsequently discovered its material supplier would no longer be able to provide the same material. Not having an alternative source for this material, our client had to demonstrate, according to FDA regulations, that a change in the source material for the device would have no effect on patient safety or product performance. They needed scientific justification as a confirmation that the previous testing results would still apply. Without this justification, the client would have to re-test and re-submit results for FDA approval, incurring additional costs and consuming valuable time.

RJ Lee Group collaborated with our client in the analysis of the replacement material and helped demonstrate that the properties and characteristics of the new material were not substantively different than the originally tested and FDA-approved material. Our technical approach and materials expertise provided a sufficient scientific basis to attain ongoing FDA approval without the need for re-testing. This helped our client maintain market position and saved the costs associated extensive re-testing and re-submission to the FDA.

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