Regulatory Compliance and Quality Assurance Support

This subcontract, managed by the Department of Veterans Affairs Network Contract Office 10, provides specialized regulatory compliance and quality assurance support. The primary objective is to ensure the supply of regulated heart valves meets all necessary legal and safety standards through comprehensive FDA compliance and the management of ISO 13485 audits. The scope of work focuses on the development and maintenance of critical regulatory documentation required for medical device distribution. Classified under NAICS code 541611, the agreement ensures that all quality assurance protocols are strictly followed to maintain the integrity and safety of heart valve supplies provided to the agency.