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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

Clinical Study Report (CSR)

Upon completion of a clinical trial, the sponsor is required to prepare a detailed report…

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E

Early Dialogues Committee (EDC)

The Early Dialogue Committee (EDC) is constituted for a specific product and the members will…

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