Medical Device Regulatory Compliance and Quality Assurance Support

This contract involves providing quality assurance, quality control, and regulatory consulting services aimed at ensuring compliance with FDA 21 CFR Part 820 and ISO 13485 standards for the production and delivery of heart valves. The services focus on maintaining stringent regulatory compliance and quality management systems that are critical in the manufacturing and supply of these medical devices. Issued as a subcontract under the NAICS code 541380, the contract supports the Department of Veterans Affairs through the 250-NETWORK Contract Office 10 (36C250). Although specific location and contact details are not provided, the contract emphasizes adherence to federal regulations and industry best practices to uphold safety and efficacy standards for medical device manufacturing, particularly heart valves. The posting date for this opportunity was March 13, 2026.