ISO 13485 Servicing vs FDA refurbishment of medical devices

Yes, there is a difference. In ISO 13485:2016, requirement 7.5.4 Servicing activities are repair and/or preventative or routine maintenance of one or more parts in a finished device, after distribution, for purposes of returning it to the safety and performance specifications.

According to Section 710(c) of FDARA, FDA differentiates the following terms: refurbishing, reconditioning, rebuilding, remarketing, repairing, remanufacturing, or other servicing of the device. Those definitions you can find in the following document: FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices https://www.fda.gov/media/113431/download

More information on service provision you can find in the following article:

• Production and service provision process in ISO 13485 https://advisera.com/13485academy/blog/2017/12/13/production-and-service-provision-process-in-iso-13485/

How record for servicing activities looks like in ISO 13485:2016 Documentation toolkit, you can find in the following link:

• Record of Servicing Activities https://advisera.com/13485academy/documentation/record-of-servicing-activities-iso-13485-2016/