With growing need and importance of “Data” for “Clinical Performance”, medical device companies need to gather data on “their” devices going forward to fulfill EU MDR goal of continuous PMCF as part of PMS of devices
MakroCare has been selected by a TOP 50 Med Device company to plan and execute PMCF study across multiple sites. To speed up the process and keep costs lower the design took advantage of retrospective + prospective methods. MakroCare performed site feasibilities based on the manufacturer preference along with required EC approvals. To make it more efficient, MakroCare is using REWOD for electronic data capture to facilitate centralized monitoring to minimize onsite visits.
The objective of this PMCF is to collect safety and effectiveness data on the device while fulfilling EU MDR ongoing performance requirements.