ContractSpecial Notice

Sole Source for Quality Management System Regulations (QMSR) Training

DEPARTMENT OF HEALTH AND HUMAN SERVICES FDA-CDRH-2025-126555
Response Deadline
Sep 9, 2025
Deadline passed
Days Remaining
0
Closed
Set-Aside
No Set aside used
Notice Type
Special Notice

Contract Opportunity Analysis

The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is seeking a contractor for Sole Source Quality Management System Regulations (QMSR) Training. The primary objective is to support the Center for Devices and Radiological Health (CDRH) in implementing training for staff in the Office of Product Evaluation and Quality (OPEQ) to facilitate the transition to the new QMSR, which will take effect on February 2, 2026. This training is crucial for enhancing the FDA's compliance, quality, and patient safety initiatives by aligning staff skills and practices with a quality-focused strategic vision. Interested parties can contact Kimberly Davis at kimberly.davis@fda.hhs.gov for further details, as there is no set-aside for this opportunity.

Classification Codes

NAICS Code
61143
Professional and Management Development Training
PSC Code
U008
EDUCATION/TRAINING- TRAINING/CURRICULUM DEVELOPMENT

Solicitation Documents

0 Files
No documents available for this solicitation.

Related Contract Opportunities

Project Timeline

postedOriginal Solicitation PostedSep 3, 2025
deadlineResponse DeadlineSep 9, 2025
expiryArchive DateSep 24, 2025

Agency Information

Department
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Sub-Tier
FOOD AND DRUG ADMINISTRATION
Office
FDA OFFICE OF ACQ GRANT SVCS

Point of Contact

Name
Kimberly Davis

Place of Performance

Silver Spring, Maryland, UNITED STATES

Official Sources