Medical Device Regulatory Compliance & Safety Certification

The contract pertains to providing regulatory compliance support for a medical device project, specifically requiring the preparation of an Attachment H certification that confirms the absence of any history of product recalls, safety alerts, or corrective actions. This service is critical for ensuring adherence to federal regulatory requirements and validating the safety and compliance posture of the medical device in question. The work is scoped under a subcontract set aside exclusively for Service-Disabled Veteran-Owned Small Businesses, reflecting a federal commitment to supporting veteran-owned enterprises in government contracting. The North American Industry Classification System code 541611 indicates this is a professional, scientific, and technical service, specifically in management consulting services related to regulatory affairs. The solicitation was posted on April 30, 2026, with a firm deadline for responses on May 7, 2026, at 2:00 PM Eastern Time. The awarding agency is the Department of Veterans Affairs through its Sac Frederick office, though no specific performance location is defined in the provided details. This contract falls under the broader framework of federal procurement regulations that prioritize compliance integrity and accountability in medical device supply chains, with the certification deliverable serving as a key documentation milestone for regulatory approval or continued market authorization. All applicants must be verified Service-Disabled Veteran-Owned Small Businesses to be eligible for consideration.