FDA-21-RFQ-1246411 CAPA System Development
Closed Solicitation Posted
- Solicitation number
- FDA-21-RFQ-1246411
- Agency
- FDA Office of Acquisition and Grant Services Food and Drug Administration, Department of Health and Human Services
- Responses due
- Set-aside
- Total Small Business
Opportunity facts
- NAICS code
- 541690 Other Scientific and Technical Consulting Services
- Place of performance
- Silver Spring, Maryland 20993, United States
Notice details come from SAM.gov. Updated .
About this opportunity
The Food and Drug Administration seeks a firm fixed-price contract to develop a Corrective Action and Preventative Action system integrated into an existing pilot analytics tool using natural language processing and machine learning. The contractor must review postmarket surveillance data sources, identify necessary data mining and cleaning efforts, and recommend an optimal methodology to build the CAPA system in accordance with objective criteria defined by FDA experts. Responses are due by August 16, 2021.
The solicitation is set aside for total small business and anticipates a directed 8(a) award to International Consulting Associates, Inc. The period of performance is 12 months to complete project management, data analysis, and system development tasks at locations in Silver Spring, Maryland. Deliverables include recommendations, prototypes, and a final CAPA system integrated into the pilot tool to analyze postmarket medical device surveillance data and identify safety issues.
Notice text
The contractor shall review postmarket surveillance data sources collected by the CDRH during the medical device life cycle, identify the data mining and cleaning efforts needed to structure or efficiently use the key data fields, and identify the best methodology needed to build a CAPA system into an existing pilot analytics tool using natural language processing and machine learning to identify signals and key items of interest to the CDRH in accordance with pre-identified objective criteria. The contractor shall present these recommendations to the CDRH for approval.
Attachments
| File | Type | Posted |
|---|---|---|
| FDA-21-RFQ-1246411_CAPA Systems .pdf |
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