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Glossary

Notified Body

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An accredited body that conducts conformity assessments for medical devices.

Other glossary definitions

U

Unanticipated Serious Adverse Device Effect (USADE)

A Serious Adverse Device Effect which by its nature, incidence, severity, or outcome has not…

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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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