Regulatory and Quality Compliance Consulting

The contract seeks consulting support to ensure compliance with FDA 21 CFR, the DLA Master List, and NIST SP 800-171 standards within the medical device supply chain. The scope includes developing and validating documentation, conducting internal audits, and implementing process controls to meet regulatory and cybersecurity requirements for defense-related medical supply operations. Work will focus on aligning supply chain procedures with federal mandates governing patient safety, data integrity, and information security, particularly in environments supporting military healthcare systems. The solicitation is structured as a subcontract under NAICS code 541611, with a response deadline of July 27, 2026, and a posting date of July 20, 2026. Performance will be conducted at a military postal address in FPO with ZIP code 09566-4008, indicating operations tied to overseas or expeditionary medical logistics. The contracting entity is the Department of Defense through its Medical Supply Chain MD SURG FSF office, emphasizing the critical nature of compliance for secure, uninterrupted delivery of surgical and medical devices to U.S. military personnel.