Recently we discussed the increased scrutiny in initial MDR certification reviews and even routine MDD audits. Building on that, in this Live! session we’ll go into details of Post-Market Clinical Follow-Up activities. Our focus will be on PMCF questions we are seeing during notified body review and best practices to help you avoid having these questions raised in the first place! We’ll describe best practices for developing a clinical evaluation matrix and our interpretation of the MDCG 2020-6 guidance on sufficient clinical evidence for legacy devices, then using it to drive an overall PMCF Strategy and execution of PMCF Plans and Reports using MDCG 2020-7 and MDCG 2020-8.
The panel will include:
Please come with questions!