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Glossary

Device Deficiency

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Inadequacy of an investigational medical device related to its identity, quality, durability, reliability, safety, or performance. This may include malfunctions, use error, or inadequacy in the information supplied by the manufacturer.

Other glossary definitions

F

Field Safety Notice (FSN)

A communication to customers and/or users sent out by a manufacturer or its representative in…

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Q

Quality Overall Summary (QOS)

An element of drug marketing applications, which provides a substantially condensed summary of the quality-related…

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