Tag Archives: Servicing

Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Servicing

By Dr. Christopher Joseph Devine
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Dr. Christopher Joseph Devine, President, Devine Guidance International

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.

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