The FDA’s quality systems regulation (QSR) and the international standard ISO 13485 have been closely aligned for years but the expectations and outcomes of FDA inspections vs. notified body audits have often been very different, leading the agency to harmonize its rule with the ISO standard. The question is, how will the FDA maintain its regulatory rigor within the 13485 framework? This session will examine the commonalities and differences between the current QSR and 13485 and provide insight into what can be expected once the proposed Quality Management System Regulation comes a reality.