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Medical Device Regulatory & Commercial Subject Matter Expert (SME) / Instructor

Active
Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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This subcontract opportunity is for a Medical Device Regulatory and Commercial Subject Matter Expert to provide in-person, instructor-led training for prime contractors on ASPR/BARDA projects. The work will be performed at the Constitution Center in Washington, DC, and involves delivering a comprehensive two-day training course. The curriculum focuses on the discovery pathway for diagnostics and software as a medical device, the US regulatory landscape including PMA and 510(k) submissions, and various CMS and FDA reimbursement programs. Qualified candidates must possess a Master's degree and at least five years of professional experience in medical device development. This is a Small Business Set Aside under NAICS code 611430, managed by the Administration for Strategic Preparedness and Response within the Department of Health and Human Services. Interested parties must respond by September 23, 2026.

General Info

Medical device expert to provide in-person training in DC by September 23, 2026.

Agency

Department Of Health And Human Services → Aspr Administration For Strategic Preparedness And ResponseView Agency

NAICS

611430 - Professional and Management Development TrainingView NAICS

Place of Performance

Washington, DC, 20024, USA

Set-Aside

SBA

Documents

This scope was carved out of HHS_26-BARDA_MedicalDeviceTraining.

The full solicitation package (1 document), including the RFP, is on the prime solicitation, not on this scope.

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Medical Device Development Instructor- Led Training

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → Aspr Administration For Strategic Preparedness And Response
ContactsNo contacts available
OfficeN/A
Organization / Agency
Department Of Health And Human Services → Aspr Administration For Strategic Preparedness And Response
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Office AddressN/A
ContactsNo contact information available

Full Description

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Performs in-person, instructor-led training for prime contractors on ASPR/BARDA projects at the Constitution Center, Washington, DC. Instructs on the discovery pathway for diagnostics and software as a device, US regulatory landscapes including 510(k) and PMA submissions, and CMS/FDA reimbursement programs. Requires a Master's degree and 5+ years of medical device development experience. Delivers a completed 2-day training course.

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