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Glossary

Patient Centricity for Biotechs

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Priority given to offering an optimal quality of life to patients along all the steps to real access of a health tech product in development with a continuous dialogue with stakeholders in which patient expertise matters, while accurate and intelligible information is delivered to patients and families.

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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D

De Novo

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

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