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Glossary

Safety concern

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An important identified risk, an important potential risk, or important missing information.

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Vigilance

From pre-market product safety to post-market surveillance, we provide integrated vigilance services…
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Clinical Safety Management

Multi-disciplinary approach to identify, assess and minimize the risks​ Clinical safety management is…

Other glossary definitions

A

Abnormal Use

Act or omission of an act by the operator or user of a medical device…

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E

Emerging Safety Issue

A safety issue considered by a marketing authorization holder to require urgent attention by the…

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