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 is a firm fixed-price purchase order awarded by the Food and Drug Administration (FDA), a civilian agency, to Health Systems Sciences, LLC, a service-disabled veteran-owned small business (SDVOSB). The contract is for annual certifications, with a total ceiling value of $77,544.84 and a performance period ending on May 31, 2027. The contract was set aside for total small business. Health Systems Sciences, LLC is an SDVOSB that specializes in providing technical certification, testing,...
This firm fixed-price purchase order was awarded by the Department of Health and Human Services Food and Drug Administration (FDA) to the Association for the Advancement of Medical Instrumentation, Inc. (AAMI), a non-profit organization, to provide Quality Systems Regulation Training on 21 CFR 820 and ISO 13485. The contract has a completion date of September 16, 2026 and a potential value of $365,699.00. AAMI has previously received prime contract awards from the Department of Veterans...
The Food and Drug Administration awarded a $1.1 million firm-fixed-price purchase order to Information Systems Audit and Control Association, Inc. (ISACA) to provide the Center for Devices and Radiological Health staff access to the CMMI Model and Development products and services. ISACA will perform as the prime contractor on this contract to support the FDA with capability maturity model integration and software development expertise from September 13, 2022 through September 29, 2024 in Silver...
The Food and Drug Administration, within the Department of Health and Human Services, awarded a $16,000 firm fixed price definitive contract to A2La Workplace Training, Inc. to obtain training on ISO standard 17025:2017. This standard concerns maintaining accreditation for testing and calibration laboratories. A2La Workplace Training, Inc. will provide the requested training services to allow the FDA's Center for Biologics Evaluation and Research to maintain its accreditation to ISO 17025. The...
This is a $125,000.00 firm fixed price purchase order awarded by the Department of Health and Human Services Food and Drug Administration to the American Society for Quality (ASQ), a non-profit organization focused on quality management training and certification. The contract is for ASQ membership and does not have a set-aside designation. ASQ has a $5 million Blanket Purchase Agreement with the FDA to provide quality management training through September 2024, with three task orders totaling...
The Department of Health and Human Services Food and Drug Administration awarded a firm-fixed price purchase order to the American Association For Laboratory Accreditation (AALA), a non-profit organization, to provide third-party accreditation by an internationally recognized and ISO 17011 conforming accrediting body for the FDA's ORS Laboratories. This contract, awarded on December 6, 2019 with a potential value of $233,162.00 and a completion date of December 31, 2024, supports the FDA's...
The Department of Health and Human Services Food and Drug Administration awarded a $393,387 definitive contract to Pacific Force Consulting Group LLC. The contract calls for the contractor to conduct quality management maturity assessments at up to nine domestic FDA facilities using their established assessment tool. Additionally, the contractor must train FDA staff to independently conduct similar evaluations. This opportunity was set aside for total small businesses and addresses the...
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 (HHS FDA) awarded a $35,751.68 firm-fixed-price purchase order to Team Results USA LLC. This purchase order is for a one-year masterclass team simulation to be delivered in Silver Spring, Maryland from September 2023 through September 2024. As the regulatory agency responsible for protecting public health through ensuring the safety and effectiveness of human and veterinary drugs, medical devices, and other products, this...