Medical Device Chemical Characterization

Chemical characterization of medical devices refers to the analysis, identification, and quantification of chemical entities (extractables and leachables) in medical device materials or components. Chemical characterization is used to assess any potential chemical interactions or risks that may affect the health of the patient in order to ensure the safety and efficacy of medical devices.

Most medical devices perform the functions of diagnosis, treatment, or mitigation through direct or indirect contact with the patient's body. Chemical characterization can predict the risk of adverse biological reactions in patients following medical device contact. Chemical characterization is an essential aspect of regulatory review and approval of medical devices in the US, EU, and most major markets worldwide. The ISO 10993 series of standards address the safety of medical devices for their intended use, with ISO 10993 -18 focusing on the chemical properties of medical devices and providing guidance for the choice of analytical techniques and thresholds.

About Us

Our company provides comprehensive chemical characterization services to medical device manufacturers to ensure the safety of medical devices and assist manufacturers through regulatory review.

Guidelines, standards, and regulations in the medical device industry advocate a risk-based approach to the safety assessment of products. Manufacturers must provide information on the chemical composition of medical devices in contact with patients as a supplement to in vivo biocompatibility studies. For example, the FDA requires manufacturers to submit data on the chemical properties of medical devices as part of their premarketing applications (PMA), premarketing notifications (510(k)), De Novo applications, and other types of medical device requests.

We are well positioned to support the chemical characterization of our customers' medical devices in accordance with regulatory guidelines and to rationally assess permissible limits for chemicals. We understand the importance of chemical characterization in the regulatory approval of medical devices and we follow ISO requirements to provide detailed information on the properties and levels of the following substances.

• Chemicals used to make medical device materials
• Chemicals used in medical device manufacturing
• Chemicals released during medical device manufacturing
• Chemicals to which patients may be exposed using medical devices

Our Chemical Characterization Methods

Our expert team relies on laboratory tests and in vitro analyses to assess the risk profile of medical devices. Chemical characterization can not only provide detailed information on the chemical formulation, purity of chemical components, impurities or degradants of medical device materials, but also provide potential risks of using such materials throughout the life cycle of medical devices, including systemic toxicity, genotoxicity, carcinogenicity, or developmental toxicity.

• We use FTIR to test for nonvolatile residues, determining the initial organic chemistry analysis
• We use GC-MS to test volatile and semi-volatile organic chemical entities to analyze chemical structures in detail
• We use ICP-MS to test inorganic, trace metal, and heavy metal chemical entities
• We test for non-volatile organic chemical entities using LC-MS
• We test the colorants using UV-Vis

We have a deep understanding of medical device materials and our laboratory is well equipped with state-of-the-art instruments. We accurately identify and analyze chemical components, providing industry-leading medical device testing services. We are your reliable partner. From test protocol design to after-sales, we provide tailored solutions to help you prove the safety of your medical devices.

If you need help or have a question, please feel free to contact us for more details.