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Glossary

CIOMS I Form

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A form used to notify the relevant authorities of the Individual Case Safety Report (ICSR) in most countries. The form has to be completed by the investigator and, after verification, provided by the sponsor to the competent authorities or to the partner company (subcontractor) in charge of the reporting.

Other glossary definitions

D

De Novo

The US Food and Drug Administration (FDA) automatically classifies Class I or II medical devices…

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N

Notified Body

An accredited body that conducts conformity assessments for medical devices.

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