SOLICITATION NOTICE
A -- Develop Regulatory Scope for Medical Hardware and Software Reliability and Maintenance
- Notice Date
- 6/28/2007
- Notice Type
- Solicitation Notice
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, MD, 20857-0001, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- Reference-Number-FDA1030940
- Response Due
- 7/13/2007
- Archive Date
- 7/28/2007
- Description
- The Food and Drug Administration intends to award a purchase order on a sole source non-competitive basis to Dr. Michael Pecht, 7027 Hunter Lane, Hyattsville, Maryland. Dr. Pecht shall inform and advise FDA on how to develop regulatory scope for medical device hardware and software reliability and maintenance. The FDA regulates medical devices which contain software. These devices, their behaviors, their risk mitigations and their engineering controls are best described as very complex systems. The medical device software provides instructions to the overall medical device system which determine its behavior when presented with all reasonably foreseeable external stimulus. In order to determine what the effect upon safety and effectiveness might be of the software, it is necessary to examine the way in which the device moves from state to state. For even moderate complexity systems this state transition study can be lengthy. Software reliability is the term used in the software development community to describe mathematically rigorous analysis techniques used to prove assertions of software reliability, safety and repeatability. Dr. Pecht shall assist FDA in developing a guidance document on medical device software reliability of the complex safety and effectiveness attributes so necessary to protect the public Health. Dr. Pecht has the expertise necessary for this requirement. He has consulted for over 50 major international electronics companies, providing expertise in strategic planning, design, test, IP and risk assessment of electronic products and system. FDA anticipates a one year period of performance. THIS IS NOT A REQUEST FOR QUOTES. However, sources may submit descriptive literature, fully documenting their capabilities, which will be considered by the agency. A determination to compete this procurement based on response(s) to this notice is solely within the discretion of the Government. The FDA intends to make an award immediately after the response date of this notice. The award will be made in accordance with FAR Part 13, Simplified Acquisition Procedures
- Record
- SN01330167-W 20070630/070628220659 (fbodaily.com)
- Source
-
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