21 CFR Part 820 Subpart N – Servicing

As servicing is not required of all medical devices, this subpart of the regulations is one of the more commonly excluded regulations from an organization’s quality system requirements. That being said, we will discuss reliability testing in this module, which is quite useful for other areas of medical devices, beyond just that of servicing and is worth the time to review. If service is required processes need to be established on how systems will be serviced and maintained. A good ‘rule of thumb’ is that if service is going to be needed or provided for the product, traceability should be maintained via a serial number (versus a lot number).