The Role of Chemical Characterization in Ensuring Medical Device Safety

Chemical characterization is a fundamental step in evaluating the safety and efficacy of medical devices. At the North American Biomedical Institute (NABI), we recognize the critical importance of this process and go above and beyond to ensure that our testing services meet the highest standards, meticulously aligned with ISO 10993-18.

In this exploration of the role of chemical characterization, we delve into the significance of understanding the materials used in medical devices. ISO 10993-18 provides guidelines for chemical characterization, extractables and leachables testing. This standard forms the basis of our testing protocols at NABI, ensuring that every assessment is conducted with precision and thoroughness.

Chemical characterization involves analyzing the composition of materials, substances, and elements that may be extracted or leached from the medical device to the human body to identify potential risks and ensure compliance with safety standards. Our state-of-the-art laboratories and team of experts are dedicated to providing a comprehensive understanding of how the materials in your medical devices interact with the body.

NABI’s approach to chemical characterization goes beyond surface-level assessments. We employ advanced methodologies and cutting-edge technologies to uncover insights that contribute to the development of top-quality and safe medical devices. They include the golden standards and techniques of tests like: Headspace GC-MS/MS, GC-MS/MS, LC-MS/MS (and HRAM LC-MS/MS), ICP-MS, and FT-IR. Our commitment to precision in every assessment sets the stage for excellence in the medical device industry.

As you embark on the journey of developing medical devices, trust NABI to provide insights that go beyond compliance. Our chemical characterization services are designed to empower you with a thorough understanding of the materials used, ensuring the safety and efficacy of your devices.