Through innovative new processes, we provide chemical characterization and complex product deformulation as well as contaminant and failure investigations to MedTech manufacturers. Our team of Ph.D. analytical chemists uses a proprietary, multi-detector approach to ensure that all extractables are accurately characterized to comply with global materials testing regulatory requirements. Additionally, our publications are frequently cited by both regulators and industry.
Chemical characterization of extractables and leachables (E&L) is a critical part of medical device biocompatibility assessment. Our industry-leading technology ensures accurate and efficient E&L testing. We have more than 40 years of experience with complex polymer systems, which gives us a unique perspective on E&L testing. Today’s medical devices are often very complex and contain a variety of different polymetric materials. Our deep polymer knowledge allows us to make better identifications and avoid unknowns.
We have extensive knowledge of the appropriate testing recommendations and play a lead role in improving standards as members of both the Association for the Advancement of Medical Instrumentation (AAMI) and International Organization for Standardization (ISO) committees. We also have vast FDA experience. We routinely partner with our study sponsors and provide experts to support discussions with FDA and other notified bodies.
Our approach minimizes the effects of response factor variation. Many other laboratories use methodologies that can produce errors in concentrations and identifications.
Leadership in medical device E&L analysis
Strong polymer expertise
Quality control with well-developed and validated analytical methods
Our biological evaluation team guides you through the complex evaluation process to get devices onto the market. We recommend the best materials for your device based on our biocompatibility expertise and deep understanding of polymer materials.
We also provide all testing outlined by ISO 10993 standards, as well as biological evaluation plans and risk assessments for developed devices. For biological evaluation plans, we use our chemical characterization testing experience to provide study design and justification. Finally, we provide toxicological risk assessments as outlined in the ISO guidance.
Product development strategy in the material selection and biological evaluation process
Biological evaluations at the pre-clinical evaluation stage
Toxicological risk assessments
Regulatory submission support for biological evaluation data
We have more than 40 years of experience performing analysis of polymeric materials – including failure analysis, material and additives identification and molecular weight characterization. We facilitate full product deformulation using quantitative and qualitative analysis.
Our fully equipped laboratory includes chromatography, microscopy and spectroscopy tools. We have more than 60 analytical techniques at our disposal to solve your most challenging problems. We routinely develop new processes based on the most advanced analytical methods to provide novel solutions.
Polymer analysis expertise
Particle and contaminant characterization
Widest range of analytical capabilities
Our product deformulation services ensure lot-to-lot product consistency, including compositional assessment and additive levels. We also help evaluate material suppliers to confirm conformity and troubleshoot manufacturing problems. Additionally, we perform market research using deformulation techniques to investigate competitive products. Our data is frequently used to support legal teams handling patent infringement cases.
Method validation and transfer can be performed for routine analysis as well.
Lot-to-lot consistency
Supplier investigations
Competitive product analysis
GLOBAL BOTTOM CTA INSTRUCTIONS:
To display custom copy instead of global copy in this section, please go to Show Global Content for Bottom CTA? toggle in the "Contents" tab to the left, toggle it off, save, and then REFRESH the page editor, the custom text will then show up and ready to be edited.
Turning the global content back on will be the same process, go to the toggle and toggle it back on, save and refresh!
United States HQ 2790 Mosside Blvd. United States (U.S.) |
Europe HQ Blenheim Court Nottingham, NG1 3BY |
©2023 RQM+ All Rights Reserved | Privacy Policy | Terms of Use