The Department of Health and Human Services Food and Drug Administration awarded a $1.91 million firm fixed price definitive contract to Information Systems Audit And Control Association, Inc. doing business as Isaca. Under the contract, Isaca will provide the CASE FOR QUALITY Voluntary Improvement Program and Medical Device Analysis - CMMI Enterprise Access and MDDAP Training Enhancement. Specifically, Isaca will deliver the CASE FOR QUALITY program and related medical device analysis...
The Department of Health and Human Services Food and Drug Administration awarded a $11,700 firm fixed price purchase order to Government And Military Certification Systems, Inc. for ISO 9001 certification surveillance audit number two and associated certificate and maintenance fees. The place of performance will be the prime contractor's offices in Silver Spring, Maryland, with work occurring between September 22nd and October 22nd, 2023. Government And Military Certification Systems, Inc....
This contract was awarded by the Food and Drug Administration (FDA), a civilian federal agency, to Government And Military Certification Systems, Inc., a self-certified small disadvantaged, woman-owned small business. The contract, valued at $65,554.15, is for ISO 9001 certification of the Center for Devices and Radiological Health's (CDRH) quality management system. It is a delivery order contract issued under the Multiple Award Schedule (MAS) contract vehicle, with a firm fixed price pricing...
This delivery order, awarded by the Department of Health and Human Services' Food and Drug Administration, is valued at one hundred sixty-three thousand three hundred ninety-three dollars and fifty cents ($163,393.50) to provide knowledge and risk management maturity towards 21st century goals. Caitta Inc., an 8A Small Business Administration-certified participant, will serve as the prime contractor performing work in Silver Spring, Maryland under a firm fixed price contract structure running...
This task order, awarded by the Department of Health and Human Services Food and Drug Administration (FDA), is for "Office of the Center Director-Quality Maturity Assessment" services with a potential value of two hundred forty thousand, two hundred thirty-nine dollars and twenty-five cents ($240,239.25). The prime contractor is Caitta Inc., an SBA Certified 8A Program Participant, and work will be performed in Silver Spring, Maryland. No set-aside designation was used for this firm...
The U.S. Food and Drug Administration (FDA) has awarded a $4,077,696.00 Firm Fixed Price, Definitive Contract to International Consulting Associates, Inc. (ICA) to develop AI-enabled user workflows and dashboards for the Center for Devices and Radiological Health (CDRH). This 8(a) sole source contract, running through September 2024, is part of the FDA's broader "ADVANCING REGULATORY SCIENCE FOR CLINICAL EVIDENCE GENERATION, ASSESSMENT, AND ANALYTICS" initiative. ICA, an...
The Department of Health and Human Services Food and Drug Administration (HHS FDA) awarded a one-year, $1.5 million firm fixed price delivery order contract to Agisol LLC. The contract is for CDER Regulatory Review Systems and Data Support under the Multiple Award Schedule contract vehicle. As the prime, Agisol will provide information technology services and solutions to support HHS FDA's Center for Drug Evaluation and Research programs. No subcontractors or set aside designations were...
The Department of Health and Human Services (HHS) Food and Drug Administration (FDA) awarded a $1,252,676.48 firm fixed-price delivery order to I4Dm, LLC, a minority-owned, small disadvantaged, veteran-owned, and HUBZone joint venture business, to provide Quality Management Information System (QMIS) program management, operations, and maintenance services. The delivery order was issued under the 8(a) Streamlined Technology Acquisition Resources for Services (8(a) STARS II) government-wide...
The U.S. Food and Drug Administration (FDA) awarded a $1,125,150 firm-fixed price purchase order to Code 13 Security, a woman-owned small business located in Fort Collins, Colorado. The contract is for the development of a Software Component/Package Risk and Vulnerability Periodic Database to support the FDA's Center for Devices and Radiological Health (CDRH) in analyzing cybersecurity vulnerabilities and risks that could impact the safety, effectiveness, and cybersecurity of medical devices...
The U.S. Department of Health and Human Services' Food and Drug Administration awarded a $3.96 million firm fixed price definitive contract to CWC Group LLC to provide quality management information system software and services in support of the Center for Drug Evaluation and Research. To be performed in Silver Spring, Maryland over a four year period through September 2024, this contract calls for CWC Group to deliver its quality management information solutions and associated services under an...