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