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ISO 13485 Servicing vs FDA refurbishment of medical devices

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Guest user Created:   Jun 19, 2020 Last commented:   Jun 23, 2020

ISO 13485 Servicing vs FDA refurbishment of medical devices

Is there a difference between ISO 13485 definition of servicing and FDA definition of refurbishment of medical devices?
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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Jun 23, 2020

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:

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

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Jun 19, 2020

Jun 23, 2020