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Glossary

ISO14155

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International standard addressing good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.

Other glossary definitions

P

Post-Authorization Efficacy Study (PAES)

A Post-Authorization Efficacy Study (PAES) is a study performed after the marketing authorization and aiming…

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S

Standard of Care

Care delivered by a healthcare provider for a specific patient which should correspond to the…

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