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 U.S. Department of Health and Human Services' Food and Drug Administration awarded a $15,000 firm fixed price purchase order to Sparrow Malcolm K. to conduct a "Risk-Informed Regulation Workshop" in Winchester, Massachusetts from August 4, 2023 through November 15, 2023. As the regulatory agency responsible for ensuring the safety and effectiveness of drugs, medical devices and other products, the FDA seeks to continually enhance its application of risk-based principles and risk...
The U.S. Food and Drug Administration awarded a $170,050 firm-fixed-price definitive contract to Iconlogic, Inc., a veteran-owned small business, to provide skilled instructional design services necessary to facilitate and deliver meaningful virtual training. The contract is intended to help the FDA's Office of Training, Evaluation, and Development (OTED) transition its current instructor-led training to a virtual format. The contract has a period of performance through September 14, 2024 and...
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...
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...
This is a firm fixed-price contract awarded by the Department of Health and Human Services (HHS) Food and Drug Administration (FDA) to the Association for the Advancement of Medical Instrumentation, Inc. (AAMI), a non-profit organization. The contract, valued at $473,920.00, is for COVID-19 related training for the FDA's Center for Devices and Radiological Health (CDRH) Case for Quality (CFQ) program. The award has a completion date of July 29, 2022. AAMI has received numerous prime federal...
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 firm fixed-price purchase order to the Association for the Advancement of Medical Instrumentation, Inc. (AAMI), a non-profit organization, for Case for Quality (CFQ) training services. The $638,800.00 contract has a completion date of September 19, 2023 and does not have a set-aside designation. AAMI has a history of receiving awards from the VA and FDA for providing memberships, subscriptions, and training...
The U.S. Food and Drug Administration (FDA) awarded a $2,932,576.44 sole source contract to Vs4S, LLC, an 8(a) certified small disadvantaged business, to provide training instructor services for courses on FDA-regulated products. The contract has an ultimate completion date of April 30, 2026. The contract was awarded as a follow-on to Vs4S's prior 8(a) set-aside contract with the FDA to provide instructional services at the agency's Silver Spring, Maryland facilities. Vs4S has extensive...
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...