Refurbished Nuclear Medicine Equipment
MEDX’s Certified® Refurbishing Process ensures your equipment is of the highest quality, meets the strictest standards and allows for the highest return on your investment. As an FDA-registered remanufacturer of gamma cameras, the rules and regulations set forth by FDA apply to every camera system that leaves our manufacturing facility.
Refurbishing Steps:
1. Selection2. De-Installation
3. Refurbishing
4. Quality Testing
5. Installation
6. Warranty and Service
Documents:
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Click on a gamma camera below for more information:
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Click here to learn more about MEDX’s responsive service options.
“A remanufacturer as defined in 21 CFR 820.3 (w) is any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that changes the finished device's performance or safety specifications or intended use. Remanufacturers are considered manufacturers. As such, these manufacturers are subject to inspection by FDA and shall meet the applicable requirements of the medical device QS regulation. These manufacturers shall establish and implement quality systems to assure the safety and effectiveness of the devices that are distributed…”
Source: Good Manufacturing Practices (GMP)/Quality System Regulation. 2004 U.S. Food and Drug Administration. 28 Jan 2004. http://www.fda.gov/CDRH/DEVADVICE/32.html/