Operations
Slide 8: Since manufacturing is a subset of the medical device production life-cycle stage, the term “manufacturing controls” is used with respect to manufacturing conducted at the device manufacturer’s location. However, most regulations use only the general term “production controls” (or similar) which pertains primarily to manufacturing, but (often) also includes labeling and packaging activities that occur in conjunction with manufacturing.
Slide 10: Since customer service and customer education are customer-facing activities, some companies prefer to place these activities under the jurisdiction of the marketing department. Functionally, however, the delivery of customer service and the delivery of customer education are operations processes which impact the correct use of the medical device.
Slide 13: The term Normal Use is from the Usability Engineering standard IEC 62366-1:2015.
Slide 16: The listed US FDA regulations pertaining to Operations processes appear in FDA 21CFR820.
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