New to medical devices and need an orientation of the creation of instructions for use (IFU)? A good place to start may be a website prepared by Ferry Vermeulen, a director at INSTRKTIV. In further preparation for the Medical Device Regulation (MDR) enforcement in the EU, Ferry prepared a guide on how to create IFU for medical devices, both European and US requirements.
You can access his guide at this link: https://instrktiv.com/en/ifu-medical-devices/
See our recent post on electronic IFU at this link: EC Draft Regulation for Electronic IFU