Although toxicological risk assessment is somewhat of a niche science, it plays an important role in establishing the safety of medical devices. The significance of this activity has increased tremendously over the last few years. The biocompatibility assessment of medical devices continues to evolve in line with changes to regulatory thinking and advances in the capabilities of scientific and technical assessments. With the latest revisions of ISO 10993 -18:2020 and EU MDR, there is a substantial focus on the material and chemical characterization of medical devices. A robust toxicological risk assessment can replace time-consuming, expensive animal toxicity studies for regulatory agency submission and approval. A qualified toxicologist or experienced professional must review the information from materials, testing or other scientific data to make an informed decision. Our scientists are highly skilled experts and subject matter specialists with professional board certifications in regulatory and toxicology work. We work closely with the client to meet the requirements set in international standards and guidelines to support patient safety for medical devices.
We offer a wide array of toxicology services, including:
Our regulatory scientists have extensive global regulatory experience. We have biological safety experts who can provide toxicological support including planning and designing studies and conducting toxicological risk assessments on an as needed basis. Whether it’s a simple material change, evaluation of a novel material, or an elaborate biological safety test, our experts can help you determine your regulatory path to approval.
We are committed to consistently performing services with high quality, that deliver exceptional results, and add value to the client’s business.
For client surveys sent in the last two quarters, we received ratings of 5/5 points (10).