Notice ID: 36C25023Q0978
Description
The Ann Arbor Medical Center, 2215 Fuller Road, Ann Arbor, Michigan is seeking to purchase document preparation and assistance services for FDA Pre-Market Approval of an Automated Control of Artificial Lung Systems to Meet Patient Metabolic Needs.
Purpose of the project: This project will advance the artificial lung control system we are developing under our current VA RR&D Merit Award (“Automated control of artificial lung systems to meet patient metabolic needs”, VA RR&D Merit I01RX003114) toward commercialization. It will ready our system for the FDA approval which is necessary for commercialization and use in humans by generating the necessary FDA documents.
Scope and methodology: During this Scope of Work, the contractor will generate the necessary documents to ready our VA Merit Award system for the FDA approval necessary for commercialization and use in humans. Contractor shall specialize in medical device software and FDA regulatory requirements.
Milestones: The System Requirements Specifications, System Architectural Specifications, System Interface Communications, and System Risk Management documents are required by the FDA and will be completed according to the following timeline.
- Complete System Requirements Specifications (SyRS – Month 3)
- Complete System Architectural Specifications (SyAD – Month 6)
- Complete System Interface Communications Descriptions (SyICD – Month 9)
- Complete System Risk Management (System Risk Analysis and Control) (SyRMP, SyRAR, SyRCM – Month 12)
