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It’s important in the marketplace for manufacturers to have in place a way for customers to return and service equipment that is not working properly. For those who refurbish or repair medical devices with the intent of putting them back into use, UL has a program that can help you assure your customers, regulators, accreditors and management team that the products comply with the current safety standards.
Rebuilt equipment certification programs:
For those companies that refurbish multiple products for redistribution, UL’s certification program may offer more flexibility. UL can establish rebuilt equipment certification programs with either the original manufacturer or another party that has the necessary facilities, technical knowledge and manufacturing skills. The program is unique to each product and facility, defining the processes, materials and parts that can be used in an refurbished medical device. The program requires an on-site inspection of the facility to demonstrate compliance with the requirements.
Companies that have rebuilt medical devices that are in compliance under the Rebuilt Certification Program are then approved to label the products with a UL Mark that specifies “Rebuilt” on it. The facilities are also covered under the UL factory surveillance program to verify ongoing compliance.
For more information on the program, download our article on the right or contact UL – Email: Medical.Inquiry@ul.com, 1-888-503-5537