Medical Device Development Training
United States of America > HEALTH AND HUMAN SERVICES, DEPARTMENT OF > OFFICE OF ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE > ASPR ADMINISTRATION FOR STRATEGIC PREPAREDNESS AND RESPONSE
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HHS_26-BARDA_MedicalDeviceTraining
]medical device development instructor- led training
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Description
The Biomedical Advanced Research and Development Authority (BARDA), within the U.S. Department of Health and Human Services, is conducting market research for a two-day, in-person instructor-led course on medical device development for up to 30 participants. The training must address discovery and concept development, preclinical and clinical studies, Investigational Device Exemptions, labeling, intellectual property, FDA regulatory pathways and submissions, expedited programs, post-market recalls, and coding, coverage, and reimbursement considerations involving FDA and CMS. The contractor must provide qualified instructors with at least five years of relevant medical device development experience, demonstrated expertise in the listed regulatory, scientific, and commercial topics, relevant educational and professional experience, and a master's degree or higher in a related field. The contractor must also develop and provide presentation slides, workbooks, handouts, and other instructional materials that comply with applicable Section 508 accessibility requirements. This is a Sources Sought/RFI for market research and acquisition planning, not a solicitation for binding offers or an award.
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Documents
| Title | Date Posted |
|---|---|
| SOO Device Development Course RFI_aspr_09152026.docx | Sep 15, 2026 12:00 PM |
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