The Importance of Material Characterization

Material characterization is essential for understanding the properties and behaviors of the materials used in medical devices. It involves analyzing polymers, metals, ceramics, and other materials to ensure they meet stringent regulatory standards. This process helps manufacturers anticipate potential issues like material degradation, chemical release, or biocompatibility failures. 


At RQM+, we use a range of advanced analytical techniques, including chromatography, microscopy, and spectroscopy, to characterize materials down to the molecular level. Our material analysis services ensure your device materials perform as expected, reducing risk and ensuring compliance with international regulations such as ISO 10993.

Ensure your materials meet global standards. Book a consultation.

Chemical Characterization for Medical Devices

Chemical characterization is critical in the regulatory approval process, especially for complex medical devices that involve polymers, metals, and other materials. At RQM+, we specialize in extractables and leachables (E&L) testing, which assesses the chemicals that may migrate from your device into the human body or environment. This testing is crucial for biocompatibility assessments and ensures your device is safe under normal usage conditions.


Our proprietary, multi-detector approach to E&L testing provides superior accuracy, eliminating unknowns and ensuring full regulatory compliance. We support FDA and EU MDR submissions by offering in-depth toxicological risk assessments and tailoring study designs to meet ISO 10993 standards.

Get precise E&L testing for your medical devices. Contact us today.

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Advanced Analytical Techniques

RQM+ offers a wide range of analytical techniques to solve complex material challenges. Our lab services cover everything from polymer identification to particle and contaminant analysis. With over 60 methods at our disposal, we can analyze both small and large molecules, helping you detect contaminants, verify supplier conformity, and ensure lot-to-lot consistency in your manufacturing process.


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, ensuring product integrity and regulatory compliance at every stage.

Why Partner with RQM+?

  • Unmatched Expertise: Our team includes chemists with decades of experience, specializing in complex polymer systems, extractables and leachables testing, and toxicological risk assessments.
  • Regulatory Insight: We help you stay ahead of evolving regulatory requirements and ensure your device meets global standards.
  • Comprehensive Services: From material characterization to regulatory submission support, we offer a full range of services to accelerate your device’s journey to market.


Partner with RQM+ for your material and chemical characterization needs.

We are passionate about your success. Tell us more about your needs so we can help.

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