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Glossary

Use error

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An act or omission of an act that results in a different medical device response than intended by the manufacturer or expected by the user. This includes slips, lapses and mistakes. However, an unexpected physiological response of the subject does not in itself constitute a use error.

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C

Cost-Effectiveness

Cost-effectiveness is the ratio of the cost of a therapeutic or preventive intervention to a…

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P

Project Management Plan

The purpose of this document is to define the scope of activities, outline responsibilities (define…

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