Medical devices

Medical devices

IITRI is able to provide a variety of services for preclinical medical device testing, and our experienced staff can work closely with you to develop customized study designs that meet your specific needs. From drug delivery to bioanalysis, we offer integrated services that support your study and deliver high-quality data quickly.

Preclinical testing of medical devices is essential to ensure safety, efficacy, and regulatory compliance before human use, especially when devices interact with biological systems or deliver therapeutic agents. At IITRI, we offer a robust suite of services to support medical device development across multiple domains. Our capabilities include GLP-compliant toxicology studies, inhalation toxicology for aerosol-based devices, and full IND-enabling programs for drug-device combinations. Our Toxicology teams can provide cytotoxicity evaluation, biomarker analysis, and support for hydrogel-based delivery systems and other innovative device platforms.

Our Microbiology and Molecular Biology departments offer microbiological testing, microbial characterization, and bioburden analysis in our (A)BSL-2 and (A)BSL-3 suites. Our Immunology team can support qualification or validation of in vitro immunology assays and possible testing of in-vitro diagnostic (IVD) medical devices for preclinical development and clinical trial support. With expertise spanning various administration routes and species, it allows us to better evaluate more device types for safety and performance.

Our preclinical CRO combines PhD scientist leadership with on-site veterinarian oversight, as well as collaborations with surgical vets for difficult procedures or device placements.

The IITRI Advantage

• Over 40 years of expertise in aerosol science and inhalation exposure study teams including PhD aerosol scientists and DABT toxicologists
• Comprehensive preclinical testing programs available to support IND and NDA submissions for drugs utilizing inhalation drug delivery
• Experience handling difficult materials including solids, liquids, and gasses