The new European Union Medical Device Regulations (MDR) and In Vitro Diagnostics Regulations (IVDR) demand, among other things, complete lifecycle traceability from product development through post-market analysis. Regulatory professionals can expect dramatic increases in the frequency and volume of documentation and more stringent traceability measures for MDR clinical evaluation reports (CERs) and IVDR performance evaluation reports (PERs).
Used by 80% of the world’s top medical device companies, DistillerSR leverages AI-powered automation, intelligent workflows, and data reuse to enable regulatory professionals and medical writers to evaluate literature in a faster more accurate, audit-ready, and compliant manner.