Europe – “UE for PDC”: Little bits of usability engineering for platform-device companies

In light of the European Medical Devices Regulation (MDR) coming fully into effect, there will be even more focus on combination product manufacturers to incorporate use-related risk management into their product development processes. However, some pharmaceutical companies leverage platform devices, and these platform devices are often past their “design freeze.” Ultimately it is the pharmaceutical company who will take ownership of, and therefore responsibility for, investigating use related risk…