Safety and Efficacy Clinical Investigations
For CE certification of medical devices
PMCF Progress
on CE Certified Medical Devices
What will be the impact of the EU MDR
on clinical data collection
in Investigator Initiated Studies?
Support the PMCF Plan
Protocol/Investigator ’s Brochure
Collect Health and Economic Data
to Obtain Approval for Reimbursement
ISO 14155/SYNOPSIS/PROTOCOL/IB