SOLICITATION NOTICE
R -- Advising to FDA on Developing Regulatory Scope for Medical Device Hardware/Software Reliablity and Maintenance
- Notice Date
- 8/20/2007
- Notice Type
- Solicitation Notice
- NAICS
- 541330
— Engineering 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
- FDA-SOL-07-00340
- Response Due
- 8/25/2007
- Archive Date
- 9/9/2007
- Small Business Set-Aside
- Total Small Business
- Description
- The Food and Drug Administration intends to award a sole source purchase order to Michael Pecht. This is not a request for competitive quotes. The contract will be made on a sole source basis in accordance with FAR Part 6.302. This purchase order will provide advising to DESE management on how to develop a regulatory scope for medical device hardware and software reliability and maintenance. BACKROUND: 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 stimuli. I n order to determine, therefore, what the effect upon safety and effectiveness might be of the software, it is necessary to examine the way in which the device moves form state to state. For even moderate complexity systems this state transition study can be lengthy. Concepts of reliability are poorly developed in the software engineering industry. SCOPE OF WORK: To inform and advise DESE management on how to develop a regulatory scope for medical device hardware and software reliability and maintenance. A period of residency inside DESE not to last more that 4 weeks by Dr. Pecht followed by a longer period throughout the contract period, as deemed necessary by DESE management and his designated appointee from University of Maryland. This agreement will continue the furtherance of the knowledge of these complex systems with in FDA and will provide the basis for a guidance document on medical device software reliability of the complex safety and effectiveness attributes so necessary to protect the public health. SOLE SOURCE JUSTIFICATION: Dr. Michael Pecht, is a Chair Professor and the Director of the CALCE Electronic Products and Systems Center at the University of Maryland. He is a Professional Products and Systems Center at the University of Maryland. He is a professional engineer, an IEEE Fellow and an ASME Fellow. He has received the 3 M Research Award, the IEEE Undergraduate Teaching Award, and the IMAPS William D. Ashman Memorial Achievement Award for his contributions. He has written eighteen books on electronic products development & use and supply chain management. He is chief editor for Microelectronics Reliability and an associate editor for the IEE Transactions on Components and Packaging Technology. 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 systems. NO REQUEST FOR QUOTE (RFQ) IS AVAILABLE. Notwithstanding, any firm that believes it is capable of providing the required service as stated herein may submit a capability statement to document its ability to provide the required services, which will be considered if received by August 25, 2007. A determination to compete this procurement based on a response to this notice is solely within the discretion of the Government. This announcement does not bind the government to any particular acquisition approach. All responses or questions regarding this posting must be in writing and can be sent via email to Dominique.Malone@fda.hhs.gov. No phone calls will be accepted. An award will be made in seven (7) calendar days from the date of this notice. This award will be made in accordance with FAR Part 13 Simplified Acquisition Procedures. All contractors doing business with the Federal Government must be registered in the Central Contractor Registration (CCR) database. The website for registration is www.ccr.gov.
- Place of Performance
- Address: 10903 New Hampshire Ave, Silver Spring, MD
- Zip Code: 20993
- Country: UNITED STATES
- Zip Code: 20993
- Record
- SN01378042-W 20070822/070820220345 (fbodaily.com)
- Source
-
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