Amendment 0001 - Quality and Regulatory Support PSC: H965
Closed Solicitation Posted
This opportunity was awarded. See the award notice from .
- Solicitation number
- 36C10X24Q0189
- Agency
- VA Strategic Acquisition Center Frederick Headquarters, Department of Veterans Affairs
- Responses due
- Set-aside
- Total Small Business
Opportunity facts
- NAICS code
- 541690 Other Scientific and Technical Consulting Services
- Place of performance
- Seattle, Washington, United States
- Points of contact
-
- Chris Binkley christopher.binkley@va.gov (240) 215-1744
Notice details come from SAM.gov. Updated .
About this opportunity
The Department of Veterans Affairs (VA) Office of Advanced Manufacturing (OAM) is seeking to establish a single-award purchase order for quality and regulatory support services under NAICS code 541690 and PSC H965. The VA requires regulatory and strategic guidance on the development and creation of patient-specific medical devices to support the delivery of healthcare within VA hospitals. Key contractor requirements include implementing and scaling a quality management system, working with the FDA on facility registrations, providing regulatory assessments, supporting strategic program development, and developing workforce competencies. Quotes are due by July 12, 2024, at 10:00 AM ET, and all questions must be submitted by June 28, 2024, at 10:00 AM ET.
This solicitation is issued as a 100% Small Business Set-Aside using the FAR 13.5 Simplified Acquisition Procedures. The performance period is a 1-year base with four 1-year option periods. The place of performance is in Seattle, WA. The VA does not identify any potential incumbents or current contractors in the solicitation.
Notice text
2 versions
Update #2 · Latest ·
**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.
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.
Update #1 ·
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.
Attachments
| File | Type | Posted |
|---|---|---|
| Questions and Answers for Solicitation 36C10XQ0189 _ Quality and Regulatory Support.pdf | ||
| S06 36C10X24Q0189 0001.pdf | ||
| S02 36C10X24Q0189 Amended 0001.pdf | ||
| S02 36C10X24Q0189.pdf |
Notice history
| Notice | Type | Posted |
|---|---|---|
| Quality and Regulatory Support PSC: H965 | Award Notice | |
| Amendment 0001 - Quality and Regulatory Support PSC: H965 | Solicitation | |
| Quality and Regulatory Support PSC: H965 | Pre-Solicitation |
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