VA RFQ: Medical Device Quality, Regulatory and Strategic Guidance Support PSC: H965

Notice ID: 36C10X24Q0189

Related Notice: 36C10X24Q0189

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.

Task: Provide guidance and facilitate leading the VA team responsible for maintaining and scaling up a quality management system (QMS) appropriate for a distributed manufacturing approach, in some cases in collaboration with DoD and 3D printing OEMs. CLIN0002, CLIN0003, CLIN0004, CLIN0005

• The Contractor shall work with VA staff, DoD staff, and VA Industry Collaborators to ensure successful maintenance of existing VA QMS documents and integration of new QMS documents with the QMS system at Walter Reed Medical Center (DoD) as appropriate. The
• Contractor shall serve as an unbiased third party to delineate pros and cons of different strategies for QMS integration between the systems. The Contractor shall also review existing (SOPs, WI’s, Component Specs, etc.), make suggestions on improvements to document management, and help write future (SOPs) that will translate to higher quality products for Service Members and Veterans.
• The Contractor shall perform internal audits per established internal audit program per released Internal Audit SOP biannually. Internal audits must cover each clause of 21CFR820 at least annually. Determine if revision to internal audit SOP is appropriate and recommend updates to the SOP.  Internal Audits include both analysis of gaps between SOP’s and the QS regulation and gaps between SOP’s/Work Instructions and records documenting, via objective evidence, the extent that QMS activities are performed to SOP’s/work instructions.

Task: Work closely with FDA collaborators to ensure registration of Point of Care (PoC) printing facilities are completed properly with patient safety as utmost importance.  CLIN0006

• The Contractor shall regularly track any FDA recommendations and amendments to recommendations regarding PoC manufacturing, which may include travel to working group meetings, conferences, and other activities hosted by or on behalf of the FDA on the topic of additive manufacturing/ 3D printing. The Contractor shall synthesize this information in written form and ensure that existing FDA-registered VHA hospitals continue to meet the requirements as laid out by FDA.

This will be a 1-Year Base and four 1-Year Option Periods.

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