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SAMDAILY.US - ISSUE OF SEPTEMBER 05, 2025 SAM #8684
SPECIAL NOTICE

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

Notice Date

9/3/2025 1:31:01 PM
 

Notice Type

Special Notice
 

NAICS

61143 —
 

Contracting Office

FDA OFFICE OF ACQ GRANT SVCS Beltsville MD 20705 USA
 

ZIP Code

20705
 

Solicitation Number

FDA-CDRH-2025-126555
 

Response Due

9/9/2025 9:00:00 AM
 

Archive Date

09/24/2025
 

Point of Contact

Kimberly Davis
 

E-Mail Address

kimberly.davis@fda.hhs.gov
(kimberly.davis@fda.hhs.gov)
 

Small Business Set-Aside

NONE No Set aside used
 

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.
 

Web Link

SAM.gov Permalink
(https://sam.gov/opp/c8de0b0047f3427cbd3f1d9713c5f854/view)
 

Place of Performance

Address: Silver Spring, MD 20993, USA

Zip Code: 20993

Country: USA
 

Record

SN07575847-F 20250905/250903230039 (samdaily.us)
 

Source

SAM.gov Link to This Notice
(may not be valid after Archive Date)

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