Regulatory and Quality Compliance Support
Contract Overview
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The contract delivers ongoing regulatory and quality compliance support for implanted medical devices, focusing on FDA reporting, post-market surveillance, quality audits, and the maintenance of accurate regulatory documentation. This work ensures adherence to evolving federal standards and facilitates continuous compliance throughout the device lifecycle. The efforts are critical to maintaining market authorization, mitigating risk, and supporting patient safety through rigorous monitoring and documentation practices. This subcontract is managed under the Department of Veterans Affairs through the 250-NETWORK Contract Office 10 (36C250) and falls under NAICS code 541611, indicating a focus on management consulting services. The contract was posted on April 30, 2026, and does not specify a set-aside status or location of performance. The scope requires specialized expertise in medical device regulations and quality systems to support federal compliance obligations without direct oversight from the original solicitation source.
General Info
Agency
NAICS
Place of Performance
OHSet-Aside
Documents
This scope was carved out of 36C25026AP3455.
The full solicitation package (1 document), including the RFP, is on the prime solicitation, not on this scope.
6515--SUPPLIES-IMPLANTABLE PULSE GENERATOR- DAYTON
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