Regulatory & Compliance Support (FDA 510(k) & Airworthiness)

The contract requires comprehensive regulatory consulting services to support an FDA 510(k) submission and airworthiness certification in accordance with MIL-HDBK-516C, encompassing all necessary documentation development and active coordination with relevant regulatory agencies. The work involves navigating complex regulatory pathways to ensure compliance with both FDA requirements for medical devices and military airworthiness standards, with a focus on preparing precise, complete, and submission-ready materials. This effort demands deep expertise in regulatory strategy, technical writing, and interagency communication to align medical device certification with defense-specific aviation safety protocols. Performance is anchored in Natick, with the contracting entity under the Department of Defense operating through W6QK Acc-apg Natick. The opportunity is structured as a subcontract under NAICS code 541690 for other professional, scientific, and technical services, and responses must be submitted by May 15, 2026, at 9:00 PM Eastern Time. The effort is critical to enabling the market access and operational deployment of a defense-related medical device, requiring seamless integration of federal regulatory frameworks and strict adherence to military technical documentation standards.