Medical Device Regulatory Compliance & Certification Support

The contract seeks consulting services to support regulatory compliance and certification for medical devices, focusing on FDA 510(k) premarket notifications, CE marking under the EU Medical Device Regulation, and ongoing maintenance of ISO 13485 quality management systems. The contractor will be responsible for guiding the client through complex regulatory pathways, ensuring documentation meets international standards, and sustaining compliance through audits and system updates. Services are expected to include strategy development, technical writing, submission preparation, and liaison with regulatory authorities to facilitate timely approvals and market access. The opportunity is issued as a subcontract under the North American Industry Classification System code 541690, managed by the Department of Veterans Affairs through its 249-NETWORK Contract Office 9. Performance is required in Louisville, Kentucky, with a zip code of 40206. The solicitation was posted on May 12, 2026, and responses must be submitted by 3:00 PM Eastern Time on May 20, 2026. No set-aside criteria or organization type restrictions are specified, and the point of contact information is not provided in the data. Interested parties must access the full solicitation through the SAM.gov portal linked in the posting.