Medical Device Regulatory Compliance & Certification Support

This contract focuses on providing consulting services to ensure regulatory compliance for medical devices. The scope includes support for FDA 510(k) submissions, assisting clients in navigating the U.S. regulatory approval process, as well as ensuring conformity with European Union Medical Device Regulation (EU MDR) requirements through CE marking. Additionally, the contract covers ongoing maintenance and support for ISO 13485 quality management systems, which are critical for maintaining consistent product quality and regulatory adherence in the medical device industry. Issued by the Department of Veterans Affairs through the 249-NETWORK Contract Office 9 (36C249), this subcontract is targeted at businesses within the NAICS code 541690 (Other Scientific and Technical Consulting Services). The place of performance is specified as Louisville, with a response deadline for proposals set for May 20, 2026. This opportunity is designed to assist medical device manufacturers in meeting stringent regulatory standards and accelerating market access across both U.S. and European markets.