Clinical evaluation is currently one of the hottest topics in the medical device industry. With the recent updates in the European Medical Device Regulation, manufacturers will be forced to keep a closer eye on their clinical evidence. This can prove troublesome for an industry that’s governed by analogue processes and legacy tools.
In order to comply with the updated regulation, the process behind clinical evaluation has to change and adhere more to modern standards. Otherwise, manufacturers will risk increased R&D costs and further loss of knowledge. If the process behind generating clinical evidence is not optimized, manufacturers will also risk prolonged time-to-market, which impacts both budgets and overall revenue.