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/

Hi Kristina, in ISO 13485, clause 7.5.4 Servicing activities, twice the word 'supplier' is mentioned. What kind of company is considered a supplier here? 

This means that service activities can be provided by your supplier, and service activities can be outsourced to some other company. Then, of course, with this outsourcing, the company must be managed as described in 4.1.5.