Delivery Order HHSF223201400022I-HHSF22301013T

This is a time and materials delivery order contract awarded by the Food and Drug Administration (FDA), a civilian agency within the Department of Health and Human Services (HHS). The contract is for the acquisition, coding, and entry of medical device adverse experience information, with a period of performance through September 30, 2020 and a ceiling value of $15,750,066.77. The prime contractor is Amtis-Heitech, LLC, a self-certified small disadvantaged business and subsidiary of Amtis, Inc.,...

This is a time and materials contract awarded by the Food and Drug Administration (FDA) to Pn-Heitech, LLC, a minority-owned small business, for medical device reporting (MDR) services in support of the Center for Devices and Radiological Health (CDRH). The contract has a ceiling value of $34,624,137.73 and a period of performance through September 29, 2025. This task order was issued against Pn-Heitech's existing indefinite delivery contract with the FDA, which has a potential total value of...

This is a 1.5-year, Time-and-Materials (T&M) task order awarded to Pn-Heitech, LLC, a minority-owned small business, to provide acquisition and management of medical device adverse event data services to support the U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH). The task order has a ceiling value of $12,836,604.29 and was awarded on September 18, 2025, with an ultimate completion date of March 13, 2027. Pn-Heitech, LLC is a small disadvantaged...

This is a firm fixed-price delivery order awarded by the Food and Drug Administration (FDA), a civilian agency within the Department of Health and Human Services (HHS), to Amtis-Heitech, LLC, a self-certified small disadvantaged business. The contract is for the acquisition, coding, and entry of medical device adverse experience information to support the FDA's mission. The award has a ceiling value of $5,737,892.58 and a period of performance through June 30, 2016. No set-aside was used for...

This contract was awarded by the Food and Drug Administration (FDA) to Akima Data Management LLC, an 8(a) certified Alaskan Native Corporation-owned small business. The $1,999,492.48 firm-fixed-price delivery order supports the development and implementation of an Enterprise Document and Record Management Platform (EDRMP) for the Center for Devices and Radiological Health (CDRH), a component of the FDA. The contract has an ultimate completion date of August 31, 2026. This award is part of a...

This is a firm fixed-price BPA call contract awarded by the Food and Drug Administration (FDA) to Global Net Services, Inc. (Globalnet Services, Inc.) for CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH) ELECTRONIC SUBMISSION (CESUB) STEADY STATE SUPPORT SERVICES. The contract has a ceiling value of $1,911,902.60 and a completion date of March 28, 2017. The contract was awarded on March 28, 2016 and is not a set-aside contract. The contract involves the provision of support services for the...

The Department of Health and Human Services Food and Drug Administration awarded a $4.9 million firm fixed price contract to Emergency Care Research Institute, doing business as Ecri, to conduct material performance study services for the Center for Devices and Radiological Health. Per the original solicitation, Ecri will systematically review scientific literature and patient safety organization databases to establish safety profiles for up to 50 commonly used materials in medical devices...

This is a firm fixed price delivery order awarded by the Food and Drug Administration (FDA) to Pn-Heitech, LLC, a minority-owned small business, for Center for Devices and Radiological Health (CDRH) premarket and postmarket tracking services. The total award value is $13,743,348.51 and the performance period runs through September 29, 2025. Pn-Heitech has previously received task orders against an Indefinite Delivery Contract with the FDA valued at up to $103 million for IT, medical device...

This is a firm-fixed-price contract awarded to Medical Records Corp. of Maryland, a small business, by the National Institutes of Health (NIH) Clinical Center. The contract is for $6,751,295.39 to provide health information management support services, including customer service, diagnostic and procedural coding and abstracting, and transcription of medical reports, letters, and pathology reports. The objective is to support patient care services and clinical research at the NIH Clinical Center....

This is a 1.5-year, firm-fixed price (FFP) task order awarded by the U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), to Pn-Heitech, LLC, a minority-owned small business, for radiological health services. The contract has a ceiling value of $1,747,314.55 and does not have a set-aside designation. Pn-Heitech, LLC is a prime contractor that provides information technology, medical device, and regulatory support services to the FDA. The company has an...