Voisin Consulting Life Sciences glossary icon
Glossary

PMCF study

Loading..
Click a letter to view all its definitions

A study carried out following the CE marking of a device and intended to answer specific questions relating to clinical safety or performance (i.e. residual risks) of a device when used in accordance with its approved labelling. 

Other glossary definitions

A

Audit

A systematic, disciplined, independent, and documented process for obtaining audit evidence and evaluating it objectively…

View definition
M

Medical Device Software

A “medical device software”, refers to a computer application that meets the legal definition of…

View definition