Global harmonisation strategies linking FDA QSR, MDSAP and EU MDR IVDR Global Harmonisation Strategies Linking FDA QSR, MDSAP and EU MDR IVDR The healthcare landscape is evolving rapidly, demanding that regulatory authorities and medical device manufacturers adopt approaches that promote global harmonisation. The convergence of regulatory frameworks such as the FDA’s Quality System Regulation (QSR), the Medical Device Single Audit Program (MDSAP), and the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) presents both challenges and opportunities. This article provides a step-by-step tutorial for regulatory, quality, clinical, and RA/QA professionals to navigate these harmonisation strategies effectively. Understanding…