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Glossary

Audit

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A systematic, disciplined, independent, and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled. 

Other glossary definitions

I

ISO14155

International standard addressing good clinical practice for the design, conduct, recording and reporting of clinical…

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N

Notified Body

An accredited body that conducts conformity assessments for medical devices.

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