Biomedical & General Engineering Consultants

The Biomedical and General Engineering Consultants subcontract, issued by the FDA Office of Acquisition and Grant Services under the Department of Health and Human Services, involves providing technical engineering reviews for medical device hardware and materials on FDA CDRH projects. The scope of work includes evaluating mechanical, electrical, software, and optics specifications, as well as assessing sterilization processes and biocompatibility. The selected contractor will be responsible for delivering comprehensive engineering review reports and validation documents while ensuring all conflict of interest checks are completed. This engagement requires specialized expertise in toxicology, human factors, biomedical engineering, and mechanical engineering. Performance of the contract is centered in Silver Spring, Maryland, under NAICS code 541330. Interested parties must adhere to the response deadline of November 17, 2026.