Product Design
Slide 3: Although the product design process function is not engaged during the product use life-cycle stage, the main goal of product design (realization of the intended use and most user needs) occurs during the product use stage.
Slide 9: With respect to labeling, FDA clarifies that “The term ‘accompanying’ is interpreted liberally to mean more than physical association with the product. It extends to posters, tags, pamphlets, circulars, booklets, brochures, instruction books, direction sheets, fillers, etc. ‘Accompanying’ also includes labeling that is brought together with the device after shipment or delivery for shipment in interstate commerce.” In other words, accompanying documents don’t necessarily have to be delivered to the customer at the same time as the medical device.
Slide 10: For quality assurance purposes, it’s important that the product design fully specifies the medical device such that there is no ambiguity about the product design specifications. If any product design specification is undefined, unclearly defined, or incorrectly defined, the operations process function (manufacturing engineering) may produce a medical device that is different from what the product design function (design engineering) intended.
Slide 13: In the US, design controls regulations appear in subpart C of FDA 21CFR820.
Acknowledgments
Slides 7-8: Cordless drill product drawings are reprinted with permission of Ranen Dahan of University of Guelph, ON, Canada.
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