Medical Device Regulatory Compliance & Certification Support

The contract requires the provision of regulatory consulting services to support medical device manufacturers in achieving compliance with FDA, Health Canada, and UL/ETL standards for submission and certification. The work involves navigating complex regulatory frameworks across multiple jurisdictions to ensure products meet requirements for market access in the United States, Canada, and other regions recognizing these certifications. The contractor must demonstrate expertise in medical device regulations, including premarket submissions, quality systems, labeling, and post-market obligations, with a focus on delivering timely and accurate guidance to facilitate approval processes. This is a small business set-aside subcontract under NAICS code 541690, issued by the Department of Veterans Affairs through its 248-NETWORK Contract Office 8. The place of performance is designated as San Juan with a zip code of 00921, though no specific city or state details beyond that are provided. The solicitation was posted on June 26, 2026, and responses are due by July 2, 2026, at 5:00 PM. Entities interested in competing must be certified as small businesses under the SBA’s Total Small Business Set-Aside criteria, and all performance must align with the regulatory and compliance expectations outlined in the scope of work.