Sole Source for Quality Management System Regulations (QMSR) Training Tender, USA - 125693657

Procurement Summary

Country: USA

Summary: Sole Source for Quality Management System Regulations (QMSR) Training

Deadline: 09 Sep 2025

Other Information

Notice Type: Tender

TOT Ref.No.: 125693657

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

Financier: Self Financed

Purchaser Ownership: Public

Tender Value: Refer Document

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Tender Details

Description

Center for Devices and Radiological Health (CDRH) requires contractor assistance to continue to support CDRH-s strategic vision for the Compliance and Quality program, and Quality and Compliance Training.

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 into effect on February 2, 2026. This will enable the FDA to strengthen its device compliance, quality, and patient-safety initiatives by aligning current skills, work processes, and practices with the quality-focused strategic vision.

For the existing FDA series of courses addressing the integration of ISO 13485 and ISO 14971, the Contractor shall:

• Provide web access to allow additional FDA staff to take the entire series of courses, previously developed by Association for the Advancement of Medical Instrumentation (AAMI).

• Support faculty led training.

• Develop a detailed FDA instructor-s guide for the existing course material.

• Continue the train-the-trainer program for CDRH staff; and

For the new QMSR course, the contractor shall

• Utilize or develop their own QMSR course to provide faculty led training for FDA staff.

• Support faculty led trainings.
Active Contract Opportunity
Notice ID : FDA-CDRH-2025-126555
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 (Updated)
Updated Published Date: Sep 03, 2025 04:33 pm EDT
Original Published Date: Sep 03, 2025 04:31 pm EDT
Updated Response Date: Sep 09, 2025 12:00 pm EDT
Original Response Date: Sep 09, 2025 12:00 pm EDT
Inactive Policy: 15 days after response date
Updated Inactive Date: Sep 24, 2025
Original Inactive Date: Sep 24, 2025
Initiative:
Classification
Original Set Aside: No Set aside used

Product Service Code: U008 - EDUCATION/TRAINING- TRAINING/CURRICULUM DEVELOPMENT
NAICS Code: 61143 - Professional and Management Development Training

Place of Performance: Silver Spring, MD 20993 USA

Documents

 Tender Notice