Tender Details

Country: USA
Summary: Sole Source for Quality Management System Regulations (QMSR) Training
UST Ref No: 125693657
Deadline: 09 Sep 2025
Financier: Self Financed
Purchaser Ownership: Government
Tender Value: Refer Document
Notice Type: Tender
Document Ref. No.: FDA-CDRH-2025-126555
Purchaser's Detail:
Login to see full purchaser details. Login to see full purchaser details. Login to see full purchaser details. Login to see full purchaser details. Login to see full purchaser details. Login to see full purchaser details. Login to see full purchaser details. Login to see full purchaser details. Login to see full purchaser details.
Login to see details
Description:
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.
Documents:

If you are registered member, kindly login to view full details of this tender notice:

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

The HEALTH AND HUMAN SERVICES, DEPARTMENT OF | FOOD AND DRUG ADMINISTRATION, a Government sector organization in USA, has announced a new tender for Sole Source for Quality Management System Regulations (QMSR) Training. This tender is published on USARFP under UST Ref No: 125693657 and is categorized as a Tender. Interested and eligible suppliers are invited to participate by reviewing the tender documents and submitting their bids before the deadline on 2025-09-09.

The estimated tender value is Refer Document, and full details, including technical specifications and submission requirements, are provided in the official tender documents. Ensure all submissions meet the criteria outlined to be considered for evaluation.