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FBO DAILY ISSUE OF MAY 02, 2008 FBO #2349
SOURCES SOUGHT

B -- Medical Device Electromagneti (EMC) testing

Notice Date
4/30/2008
 
Notice Type
Sources Sought
 
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, Maryland, 20857-0001
 
ZIP Code
20857-0001
 
Solicitation Number
FDA081043007
 
Point of Contact
Roberta M Richardson, Phone: 301-827-7175
 
E-Mail Address
roberta.richardson@fda.hhs.gov
 
Description
Set-up and performance of medical device testing THIS IS NOT A SOLICITATION. THIS IS NOT A REQUEST FOR PROPOSAL (RFP), INVITATION FOR BID (IFB), REQUEST FOR QUOTES (RFQ), REQUEST FOR APPLICATION (RFA) OR AN ANNOUNCEMNT OF A SOLICITATION AND DOES NOT ASSUME THE GOVERNMENT WILL AWARD A CONTRACT OR PROCEED WITH ANY OF THE ABOVE SOLICITATIONS IN THE NEAR FUTURE. THIS NOTICE IS ONLY FOR MARKET RESEARCH PURPOSES. Based on capability statements received from SMALL BUSINESSES ONLY from this announcement, this acquisition may be solicited as a 100% Small Business Set-Aside or as a full and open competition. The NAICS Code is 541690. All Small Business Concerns, including 8(a), veteran-owned small business, service-disabled veteran owned small business, HUBZone small business, small disadvantaged business, and women owned small business are encouraged to respond to this notice. Scope of Work Set-up Center for Devices and Radiological Health (CDRH) CDRH owned GTEM (Gigahertz Transverse ElectroMagnetic Cell) facility to perform medical device medical device electromagnetic compatibility (EMC) testing, perform EMC testing on designated medical devices, and modify and upgrade GTEM control software as needed. A final report covering test setup and results will be written. All work to be done on-site at CDRH EMC laboratories, 10903 New Hampshire Avenue, Building 62, Silver Spring, Maryland. This job requires highly specialized skills for radio frequency (RF) test and measurements specific to the GTEM facility for medical device electromagnetic compatibility (EMC) immunity testing. This includes configuring appropriate EMC and medical device systems and instrumentation, verifying immunity testing exposure fields using special instrumentation and fiber optic connected systems, and computer interfaces and appropriate computer programming knowledge and skills. The contractor must have knowledge and expertise with the configuration and precision field mapping and control systems of the CDRH GTEM system, EMC specific computer instrument interfacing and data capture and analysis, and specialized medical device EMC testing processes and methods. FDA regulates the safety and effectiveness of active (electrically powered) medical devices that may be put at risk from the emissions by high-power radar-like emitters being evaluated for use near commercial airports. The CDRH GTEM facility was designed and has been extensively used to perform EMC tests and measurements for medical device safety and effectiveness. FDA has immediate need to configure and use this facility as quickly as possible to perform laboratory research and medical device EMC tests and measurements.
 
Web Link
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=fcf9647c3c1cf65449527f5339e8cdfe&tab=core&_cview=1)
 
Place of Performance
Address: 10903 New Hampshire Avenue, Building 62, Silver Spring, Maryland, 20993, United States
Zip Code: 20993
 
Record
SN01563848-W 20080502/080430221147-fcf9647c3c1cf65449527f5339e8cdfe (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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