This brief examines global market access challenges for medical device and in-vitro diagnostic companies from a regulatory affairs viewpoint. It highlights the growing complexity and variability of global regulations and the need to move beyond a US- and EU-centric mindset. IQVIA introduces the concept of “design for registration,” encouraging early identification of global requirements during product design. By using connected, intelligence-driven QMS and RIM solutions, organizations can improve regulatory predictability, reduce risk, accelerate global launches, and better balance patient safety with commercial performance.

Join for free to read