Fast Tracked PMCF Activities
This case study looks at fast tracked PMCF activities and how CLIN-r+ supported one manufacturer with their Clinical Data Acquisition for EU MDR submission from an MDD Certificate based on Equivalence.
This case study looks at fast tracked PMCF activities and how CLIN-r+ supported one manufacturer with their Clinical Data Acquisition for EU MDR submission from an MDD Certificate based on Equivalence.
The EU MDR increases the need for Post Market Surveillance (PMS), and therefore Post Market Clinical Follow up (PMCF). CLIN-r+ explains how manufacturers will need to collect more clinical evidence and improve data quality and management for each device.