What If Your Audit Logs Could Talk

Since the 1990s, when the European Union introduced its first comprehensive regulatory framework for medical devices, the European Directive on medical devices was introduced, and especially today with the new EU MDR/IVDR regulations, the volume and complexity of documentation required for regulatory submissions and ongoing compliance have increased dramatically. Manufacturers are now tasked with compiling extensive and continually evolving datasets into multiple, overlapping reports to meet stringent audit and review processes. . A recent position paper by MedTech Europe highlights that the current PDF-based process for technical documentation submissions is highly inefficient and burdensome for manufacturers. The digitalization of Technical Documentation suggests a transition to a harmonized, item-based content management approach.