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Glossary

Abnormal Use

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Act or omission of an act by the operator or user of a medical device as a result of conduct which is beyond any means of risk control by the manufacturer. 

Other glossary definitions

C

Consolidated Parallel Consultation

Products selected for this pathway will have an EDC composed of the EDWP members and…

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U

Unexpected adverse reaction

An adverse reaction, the nature, severity or outcome of which is not consistent with the…

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