Implantable Pulse Generator Supply

The contract entails the procurement and delivery of implantable pulse generators as finished medical devices, with strict adherence to FDA regulations and ISO 13485 quality management standards to ensure safety, efficacy, and regulatory compliance throughout manufacturing and supply. The equipment is intended for medical use, and the contractor must maintain full control over design, production, testing, and documentation to meet the rigorous requirements for implantable Class III devices under U.S. medical device law. This subcontract is issued under the Department of Veterans Affairs through the 250-NETWORK Contract Office 10, with a NAICS code of 339112 indicating classification within the medical equipment and supplies manufacturing sector. The contract was posted on July 2, 2026, and performance location details are unspecified, though delivery must align with VA medical facility needs. All units must be fully compliant with international quality systems and U.S. regulatory frameworks, and the subcontractor is expected to provide traceable, validated, and auditable production records for each device delivered.