Sole Source for Quality Management System Regulations (QMSR) Training

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.