Process Stream Blog Important Changes from the eMDR from Our Solutions Experts

Medical Device Post Market Surveillance Coding The FDA eMDR eSubmission Gateway and the EU MIR forms are implementing new changes to fields and structures to harmonize codes on the IMDRF code sets. There has been a slow march to harmonization within the FDA. However, full-harmonization has been added, and is now reflected in the system. Learn more as our QMS solutions experts dive into some details below, and be sure to download our exclusive FDA/EU Harmonization Checklist & Best Practices one-sheet via the link at the bottom!