The report discusses the quality, safety and effectiveness of medical device servicing by OEMs and third parties.
If your establishment is entering equipment into commerce that is deemed a finished medical device and product servicing is expected during the normal product life-cycle, then compliance with §820.200 is mandated by the QSR. Mandatory means “not optional” in the eyes of the regulatory gods at FDA.
Servicing is a functional requirement, mandated by the Quality System Regulation, and often overlooked by device manufacturers. Though 21 CFR, Part 820.200 is often associated with capital equipment, manufacturers of disposable medical devices still must consider the requirement. It really is a mission critical assignment to provide adequate servicing for equipment deployed in healthcare facilities, while ensuring all of the relevant servicing activities are recorded, tracked trended, analyzed, etc.