BIOMASTER BIOMONITOR III
Completed · 2020 until 2022
Ammann Peter, Schneider Irene
This study is a post-market clinical follow-up (PMCF) study to identify and evaluate residual risks associated with the use of the BIOMONITOR III that are discovered or remain even after risk analysis, risk mitigation and successful conformity assessment. Furthermore, this study will also provide additional data as required by regulatory authorities outside of the CE-region.
SADE-free rate related to BIOMONITOR III including incision and insertion tool set until 3-month follow-up