Notice of Intent to Sole Source - Quality and Compliance Training Support Tender

Procurement Summary

Country: USA

Summary: Notice of Intent to Sole Source - Quality and Compliance Training Support

Deadline: 08 Sep 2025

Other Information

Notice Type: Tender

TOT Ref.No.: 125761498

Document Ref. No.: FDA-CDRH-2025-126555-1

Financier: Self Financed

Purchaser Ownership: Public

Tender Value: Refer Document

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Tender Details

Description

Notice of Intent to Sole Source - Quality and Compliance Training Support



The Food and Drug Administration (FDA) intends to award a sole source, firm fixed price type contract to Association for the Advancement of Medical Instrumentation, 901 N. Glebe Road, Suite 300

Arlington, VA 22203, in accordance with the authority under FAR Part 6.302-1 - Only one responsible source and no other supplies or services will satisfy agency requirements. This procurement is being conducted in accordance with Federal Acquisition Regulations (FAR) Part 15. The NAICS code is 611430 - Professional and Management Development Training.



The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation-s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable, and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

The primary objective of this requirement is to support CDRH-s strategic vision for the Compliance and Quality program and CDRH reviewers by (1) implementing existing training for the staff in the Office of Product Evaluation and Quality (OPEQ) to support the regulatory transition of 21 CFR Part 820 from the Quality System Regulation (QS Reg) to the Quality Management System Regulation (QMSR). This training addresses the integration of the ISO14971 standard for risk-management in medical devices, with the ISO13485 standard for quality management system requirements for medical device manufacturers and supporting CDRH-s capability for CDRH staff to deliver the training in the future; and (2) deliver training on the new QMSR (21 CFR Part 820) which will go in...
Active Contract Opportunity
Notice ID : FDA-CDRH-2025-126555-1
Related Notice
Department/Ind. Agency : HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Sub-tier : FOOD AND DRUG ADMINISTRATION
Office: FDA OFFICE OF ACQ GRANT SVCS
General Information
Contract Opportunity Type: Special Notice (Original)
Original Published Date: Sep 04, 2025 11:52 am EDT
Original Response Date: Sep 08, 2025 12:00 pm EDT
Inactive Policy: 15 days after response date
Original Inactive Date: Sep 23, 2025
Initiative:
Classification
Original Set Aside: No Set aside used
Product Service Code: U008 - EDUCATION/TRAINING- TRAINING/CURRICULUM DEVELOPMENT
NAICS Code: 611430 - Professional and Management Development Training

Place of Performance: Silver Spring, MD 20993 USA

Documents

 Tender Notice