Regulatory Path

The envisaged regulatory path approach is as follows:

AVP BV runs the design verification and validation together with LUMC
Nimbler medical will construct and finalize the AVP product file (a.o. technical summary and manufacturing plan) according to the MDR
Application and execution of product validation organized by Nimbler medical
End point for CE submission is a full product technical file, design history file and master record
Legal manufacturer submits documentation at notified body for audit and CE registration
Preparations of FDA submission and approval