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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

P

Post-Authorization Safety Study (PASS)

A Post-Authorization Safety Study (PASS) is a study performed after the marketing authorization and aiming…

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R

Redaction

In relation to Policy 70, the process of permanently obscuring CCI or PPD in the…

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