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Glossary

Appropriately Reduce (risk)

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The reduction of risk to an acceptable level as determined by the manufacturer and regulatory authority (reducing risk as low as reasonably practicable, reducing risk as low as reasonably achievable, or reducing risk as far as possible) without adversely affecting the benefit-risk ratio. 

Other glossary definitions

P

Patient Reported Outcome (PRO)

A measurement based on a report that comes directly from the patient (i.e., study subject)…

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E

Expected Life of a Device

The time that a device is expected to remain functional after it is placed into…

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