{"canonical":"https://abierto.us/opportunities/36c10x24q0189","key":"36C10X24Q0189","url":"https://abierto.us/opportunities/36c10x24q0189","title":"Quality and Regulatory Support PSC: H965","solicitation_number":"36C10X24Q0189","notice_type":"a","open":false,"response_deadline":"2024-07-12T14:00:00Z","first_posted":"2024-06-06","last_posted":"2024-08-13","department":"VETERANS AFFAIRS, DEPARTMENT OF","subagency":"VETERANS AFFAIRS, DEPARTMENT OF","office":"SAC FREDERICK (36C10X)","naics":"541690","psc":"H965","set_aside":"SBA","place_state":"WA","place_county":"53033","place_county_name":"King County","place_city":"5363000","place_city_name":"Seattle","winner":"LG STRATEGIES LLC","award_amount":"4358100.00","publications":[{"notice_id":"025d4e93b70c4e1da58467b999ae3bd6","title":"Quality and Regulatory Support PSC: H965","solicitation_number":"36C10X24Q0189","notice_type":"p","base_type":"p","posted":"2024-06-06","posted_at":null,"due_at":"2024-06-21T14:00:00Z","due_date":"2024-06-21","cancelled":null,"archived":null,"archive_date":"2024-07-06","award_number":null,"awardee_name":null,"amount":null,"link_sam":"https://sam.gov/workspace/contract/opp/025d4e93b70c4e1da58467b999ae3bd6/view","enriched":false,"history":[]},{"notice_id":"6cc699ba4f1e47a18d8c18ca517d6b7d","title":"Quality and Regulatory Support PSC: H965","solicitation_number":"36C10X24Q0189","notice_type":"p","base_type":"p","posted":"2024-06-06","posted_at":null,"due_at":"2024-07-13T14:00:00Z","due_date":"2024-07-13","cancelled":null,"archived":null,"archive_date":"2024-07-28","award_number":null,"awardee_name":null,"amount":null,"link_sam":"https://sam.gov/workspace/contract/opp/6cc699ba4f1e47a18d8c18ca517d6b7d/view","enriched":false,"history":[]},{"notice_id":"70d05644b2e140a19ba6805a8c833456","title":"Quality and Regulatory Support PSC: H965","solicitation_number":"36C10X24Q0189","notice_type":"o","base_type":"p","posted":"2024-06-21","posted_at":null,"due_at":"2024-07-12T14:00:00Z","due_date":"2024-07-12","cancelled":null,"archived":null,"archive_date":"2024-07-27","award_number":null,"awardee_name":null,"amount":null,"link_sam":"https://sam.gov/workspace/contract/opp/70d05644b2e140a19ba6805a8c833456/view","enriched":false,"history":[]},{"notice_id":"7095d6ad4518486dafe81c770978a3c6","title":"Amendment 0001 - Quality and Regulatory Support PSC: H965","solicitation_number":"36C10X24Q0189","notice_type":"o","base_type":"o","posted":"2024-07-01","posted_at":null,"due_at":"2024-07-12T14:00:00Z","due_date":"2024-07-12","cancelled":null,"archived":null,"archive_date":"2024-07-27","award_number":null,"awardee_name":null,"amount":null,"link_sam":"https://sam.gov/workspace/contract/opp/7095d6ad4518486dafe81c770978a3c6/view","enriched":false,"history":[]},{"notice_id":"eb94e5cd653145d6b3a37f3ee5d4e7bf","title":"Quality and Regulatory Support PSC: H965","solicitation_number":"36C10X24C0027","notice_type":"a","base_type":"o","posted":"2024-08-13","posted_at":null,"due_at":null,"due_date":null,"cancelled":null,"archived":null,"archive_date":"2024-08-28","award_number":"36C10X24C0027","awardee_name":"LG STRATEGIES LLC Austin","amount":"4358100.00","link_sam":"https://sam.gov/workspace/contract/opp/eb94e5cd653145d6b3a37f3ee5d4e7bf/view","enriched":false,"history":[]}],"latest_notice_id":"eb94e5cd653145d6b3a37f3ee5d4e7bf","first_type":"p","notices":[{"dates":{"posted":"2024-06-06","response_deadline":{"raw":"2024-06-21T10:00:00-04:00","utc":"2024-06-21T14:00:00Z","date":"2024-06-21","time":"10:00:00","utc_offset_seconds":-14400}},"links":{"sam":"https://sam.gov/workspace/contract/opp/025d4e93b70c4e1da58467b999ae3bd6/view"},"naics":{"codes":["541690"],"primary":"541690"},"title":"Quality and Regulatory Support PSC: H965","agency":{"office":{"code":"36C10X","name":"SAC FREDERICK (36C10X)"},"subtier":{"code":"3600","name":"VETERANS AFFAIRS, DEPARTMENT OF"},"department":{"code":"036","name":"VETERANS AFFAIRS, DEPARTMENT OF"},"office_address":{"zip":"21703","city":"FREDERICK","state":"MD","country":"USA"},"organization_type":"OFFICE"},"status":{"active":false,"archive_date":"2024-07-06","archive_type":"auto15"},"contacts":[{"name":"Chris Binkley","role":"primary","email":"christopher.binkley@va.gov"}],"base_type":{"code":"p","label":"Presolicitation"},"notice_id":"025d4e93b70c4e1da58467b999ae3bd6","set_aside":{"code":"SBA","label":"Total Small Business Set-Aside (FAR 19.5)"},"provenance":{"extract":{"url":"https://s3.amazonaws.com/falextracts/Contract%20Opportunities/Archived%20Data/FY2024_archived_opportunities.csv","etag":"\"d582488fe153a9f11bf629913d176ffc-137\"","fetched_at":"2026-09-16T19:07:39.720164Z","row_sha256":"7bb4e62bfe37368368647c028fa9d718e598ba1ff2b7700d86bf42762565d967","last_modified":"2026-09-13T14:47:40Z"},"updated_at":"2026-09-16T19:07:39.720164Z","first_seen_at":"2026-09-16T19:07:39.720164Z"},"description":{"text":"The Department of Veterans Affairs (VA) intends to issue solicitation 36C10X24Q0189 on or about June 21st, 2024. The VA is seeking to establish a single Firm-Fixed Price (FFP) contract for services under the North American Industry Classification System (NAICS) code 541690 and Product Service Code (PSC) H965. The government will utilize the FAR 13.5 Simplified Acquisition Procedures for this procurement. The proposed solicitation will be issued as a Total Small-Business Set-Aside. The Small Business Size Standard is $19 Million. All responsible sources meeting the set-aside requirements may submit an offer which shall be considered by the agency. The Department of Veterans Affairs (VA) Office of Advanced Manufacturing (OAM), under the Office of Healthcare Innovation and Learning (OHIL), has a requirement for medical device regulatory and strategic guidance on development and creation of patient specific medical devices to support the delivery of health care within Veterans Health Administration (VHA) hospitals. OAM develops medical devices within VHA and requires support from a capable partner with deep experience in regulated medical device development, particularly involving patient specific designs and additive manufacturing. Additionally, the contract includes provisions for supporting OAM capabilities via services provided. If a solicitation is released, then it and any additional documents will be available on www.Sam.gov. It is the offeror's responsibility to monitor this website for the release of the solicitation and amendments (if any). Potential offerors will be responsible for downloading their own copy of the solicitation and amendments (if any).","origin":"extract"},"notice_type":{"code":"p","label":"Presolicitation"},"schema_version":1,"solicitation_number":"36C10X24Q0189","place_of_performance":{"city":{"name":"Seattle"},"state":{"code":"WA"},"country":{"code":"USA"}},"product_service_code":"H965"},{"dates":{"posted":"2024-06-06","response_deadline":{"raw":"2024-07-13T10:00:00-04:00","utc":"2024-07-13T14:00:00Z","date":"2024-07-13","time":"10:00:00","utc_offset_seconds":-14400}},"links":{"sam":"https://sam.gov/workspace/contract/opp/6cc699ba4f1e47a18d8c18ca517d6b7d/view"},"naics":{"codes":["541690"],"primary":"541690"},"title":"Quality and Regulatory Support PSC: H965","agency":{"office":{"code":"36C10X","name":"SAC FREDERICK (36C10X)"},"subtier":{"code":"3600","name":"VETERANS AFFAIRS, DEPARTMENT OF"},"department":{"code":"036","name":"VETERANS AFFAIRS, DEPARTMENT OF"},"office_address":{"zip":"21703","city":"FREDERICK","state":"MD","country":"USA"},"organization_type":"OFFICE"},"status":{"active":false,"archive_date":"2024-07-28","archive_type":"auto15"},"contacts":[{"name":"Chris Binkley","role":"primary","email":"christopher.binkley@va.gov"}],"base_type":{"code":"p","label":"Presolicitation"},"notice_id":"6cc699ba4f1e47a18d8c18ca517d6b7d","set_aside":{"code":"SBA","label":"Total Small Business Set-Aside (FAR 19.5)"},"provenance":{"extract":{"url":"https://s3.amazonaws.com/falextracts/Contract%20Opportunities/Archived%20Data/FY2024_archived_opportunities.csv","etag":"\"d582488fe153a9f11bf629913d176ffc-137\"","fetched_at":"2026-09-16T19:07:39.720164Z","row_sha256":"fc703dbd4159e74a02d776bd6329e4f3ffab31c94437a98834813c7ee684d6e4","last_modified":"2026-09-13T14:47:40Z"},"updated_at":"2026-09-16T19:07:39.720164Z","first_seen_at":"2026-09-16T19:07:39.720164Z"},"description":{"text":"The Department of Veterans Affairs (VA) intends to issue solicitation 36C10X24Q0189 on or about July 13th, 2024. The VA is seeking to establish a single Firm-Fixed Price (FFP) contract for services under the North American Industry Classification System (NAICS) code 541690 and Product Service Code (PSC) H965. The government will utilize the FAR 13.5 Simplified Acquisition Procedures for this procurement. The proposed solicitation will be issued as a Total Small-Business Set-Aside. The Small Business Size Standard is $19 Million. All responsible sources meeting the set-aside requirements may submit an offer which shall be considered by the agency. The Department of Veterans Affairs (VA) Office of Advanced Manufacturing (OAM), under the Office of Healthcare Innovation and Learning (OHIL), has a requirement for medical device regulatory and strategic guidance on development and creation of patient specific medical devices to support the delivery of health care within Veterans Health Administration (VHA) hospitals. OAM develops medical devices within VHA and requires support from a capable partner with deep experience in regulated medical device development, particularly involving patient specific designs and additive manufacturing. Additionally, the contract includes provisions for supporting OAM capabilities via services provided. If a solicitation is released, then it and any additional documents will be available on www.Sam.gov. It is the offeror's responsibility to monitor this website for the release of the solicitation and amendments (if any). Potential offerors will be responsible for downloading their own copy of the solicitation and amendments (if any).","origin":"extract"},"notice_type":{"code":"p","label":"Presolicitation"},"schema_version":1,"solicitation_number":"36C10X24Q0189","place_of_performance":{"city":{"name":"Seattle"},"state":{"code":"WA"},"country":{"code":"USA"}},"product_service_code":"H965"},{"dates":{"posted":"2024-06-21","response_deadline":{"raw":"2024-07-12T10:00:00-04:00","utc":"2024-07-12T14:00:00Z","date":"2024-07-12","time":"10:00:00","utc_offset_seconds":-14400}},"links":{"sam":"https://sam.gov/workspace/contract/opp/70d05644b2e140a19ba6805a8c833456/view"},"naics":{"codes":["541690"],"primary":"541690"},"title":"Quality and Regulatory Support PSC: H965","agency":{"office":{"code":"36C10X","name":"SAC FREDERICK (36C10X)"},"subtier":{"code":"3600","name":"VETERANS AFFAIRS, DEPARTMENT OF"},"department":{"code":"036","name":"VETERANS AFFAIRS, DEPARTMENT OF"},"office_address":{"zip":"21703","city":"FREDERICK","state":"MD","country":"USA"},"organization_type":"OFFICE"},"status":{"active":false,"archive_date":"2024-07-27","archive_type":"auto15"},"contacts":[{"name":"Chris Binkley","role":"primary","email":"christopher.binkley@va.gov"}],"base_type":{"code":"p","label":"Presolicitation"},"notice_id":"70d05644b2e140a19ba6805a8c833456","set_aside":{"code":"SBA","label":"Total Small Business Set-Aside (FAR 19.5)"},"provenance":{"extract":{"url":"https://s3.amazonaws.com/falextracts/Contract%20Opportunities/Archived%20Data/FY2024_archived_opportunities.csv","etag":"\"d582488fe153a9f11bf629913d176ffc-137\"","fetched_at":"2026-09-16T19:07:39.720164Z","row_sha256":"8e998fc79efd1589e3e56354d2605d9c17fb6d68159eccf1f615ffe880e0d791","last_modified":"2026-09-13T14:47:40Z"},"updated_at":"2026-09-16T19:07:39.720164Z","first_seen_at":"2026-09-16T19:07:39.720164Z"},"description":{"text":"Overview: The Department of Veterans Affairs (VA) is seeking to establish a single-award purchase order for services under the North American Industry Classification System (NAICS) code 541690 and Product Service Code (PSC) H965. The government will utilize the FAR 13.5 Simplified Acquisition Procedures for this procurement. This solicitation is issued on as a 100% Small Business Set-Aside. Scope: The Department of Veterans Affairs (VA) Office of Advanced Manufacturing (OAM), under the Office of Healthcare Innovation and Learning (OHIL), has a requirement for medical device regulatory and strategic guidance on development and creation of patient specific medical devices to support the delivery of health care within Veterans Health Administration (VHA) hospitals. Performance Period: This will be a 1-Year Base and four 1-Year Option Periods. Contractor Requirements and Submission Instructions: See Section E of the attached solicitation for details. Quotes shall be received on or before July 12, 2024, at 10:00 AM ET. All quotes shall be sent to the Contracting Officer (Christopher.Binkley@va.gov). Note: Quotes received after the due date and time shall not be considered. All questions must be submitted in writing to the Contracting Officer (Christopher.Binkley@va.gov). THE CUT-OFF DATE AND TIME FOR RECEIPT OF QUESTIONS IS June 28, 2024, at 10:00 AM ET. Additional Information: Additional information, amendments, and updates to this solicitation will be posted on SAM.gov. Interested parties are responsible for monitoring the site for updates.","origin":"extract"},"notice_type":{"code":"o","label":"Solicitation"},"schema_version":1,"solicitation_number":"36C10X24Q0189","place_of_performance":{"city":{"name":"Seattle"},"state":{"code":"WA"},"country":{"code":"USA"}},"product_service_code":"H965"},{"dates":{"posted":"2024-07-01","response_deadline":{"raw":"2024-07-12T10:00:00-04:00","utc":"2024-07-12T14:00:00Z","date":"2024-07-12","time":"10:00:00","utc_offset_seconds":-14400}},"links":{"sam":"https://sam.gov/workspace/contract/opp/7095d6ad4518486dafe81c770978a3c6/view"},"naics":{"codes":["541690"],"primary":"541690"},"title":"Amendment 0001 - Quality and Regulatory Support PSC: H965","agency":{"office":{"code":"36C10X","name":"SAC FREDERICK (36C10X)"},"subtier":{"code":"3600","name":"VETERANS AFFAIRS, DEPARTMENT OF"},"department":{"code":"036","name":"VETERANS AFFAIRS, DEPARTMENT OF"},"office_address":{"zip":"21703","city":"FREDERICK","state":"MD","country":"USA"},"organization_type":"OFFICE"},"status":{"active":false,"archive_date":"2024-07-27","archive_type":"auto15"},"contacts":[{"name":"Chris Binkley","role":"primary","email":"christopher.binkley@va.gov"}],"base_type":{"code":"o","label":"Solicitation"},"notice_id":"7095d6ad4518486dafe81c770978a3c6","set_aside":{"code":"SBA","label":"Total Small Business Set-Aside (FAR 19.5)"},"provenance":{"extract":{"url":"https://s3.amazonaws.com/falextracts/Contract%20Opportunities/Archived%20Data/FY2024_archived_opportunities.csv","etag":"\"d582488fe153a9f11bf629913d176ffc-137\"","fetched_at":"2026-09-16T19:07:39.720164Z","row_sha256":"6d5d8439230f7593cfabe7cbb2f9f647b2f1e57be2d01bb717fa07f4fd328d13","last_modified":"2026-09-13T14:47:40Z"},"updated_at":"2026-09-16T19:07:39.720164Z","first_seen_at":"2026-09-16T19:07:39.720164Z"},"description":{"text":"**Amendment 0001** The purpose of amendment 0001 is to provide Government responses to vendor questions. Please see the attached Questions and Answers and amended Solicitation. All changes are highlighted in yellow. The proposal submission response time remains 7/12/2024 at 10:00 AM ET. Overview: The Department of Veterans Affairs (VA) is seeking to establish a single-award purchase order for services under the North American Industry Classification System (NAICS) code 541690 and Product Service Code (PSC) H965. The government will utilize the FAR 13.5 Simplified Acquisition Procedures for this procurement. This solicitation is issued on as a 100% Small Business Set-Aside. Scope: The Department of Veterans Affairs (VA) Office of Advanced Manufacturing (OAM), under the Office of Healthcare Innovation and Learning (OHIL), has a requirement for medical device regulatory and strategic guidance on development and creation of patient specific medical devices to support the delivery of health care within Veterans Health Administration (VHA) hospitals. 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