- Country: USA
- Summary: Notice of Intent to Sole Source - Quality and Compliance Training Support
- UST Ref No: 125761498
- Deadline: 08 Sep 2025
- Financier: Self Financed
- Purchaser Ownership: Government
- Tender Value: Refer Document
- Notice Type: Tender
- Document Ref. No.: FDA-CDRH-2025-126555-1
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- Description:
- 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... - Documents:
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CLICK HERE TO LOGINNotice of Intent to Sole Source - Quality and Compliance Training Support - 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 Notice of Intent to Sole Source - Quality and Compliance Training Support. This tender is published on USARFP under UST Ref No: 125761498 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 2025-09-08.
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.
