Remanufactured Nuclear Medicine Equipment
MEDX’s exclusive remanufacturing process means the nuclear medicine camera you purchase meets a higher standard than typical pre-owned or refurbished systems. We are regularly inspected to ensure our processes meet FDA QSR and GMP regulations guaranteeing safe and high-quality equipment. All of our remanufactured nuclear medicine equipment compares favorably to any new nuclear camera and outperforms the original manufacturer’s equipment specifications. Our remanufactured nuclear medicine equipment includes a new computer system with cutting-edge correction technology and the latest processing techniques. These benefits set us apart from other companies who refurbish or sell pre-owned equipment.
Click on a gamma camera below for more information:
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“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/