FDA’s QMSR Shift:
What It Means and What You Need to Know
This webinar provides an overview of the FDA’s transition from the Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR), which follows ISO 13485:2016. The session explains regulatory changes, outlines operational impacts, and presents guidance for manufacturers and quality professionals regarding the February 2026 deadline.
Attendees will receive analysis and examples related to compliance requirements,
risk-based quality management, and approaches to global harmonization.
Meet the Speakers
Yasily Ogando Roa
Yasily is a globally recognized expert in Regulatory Affairs and Quality Assurance, with 30+ years of experience driving compliance, operational excellence, and innovation in the medical device industry. She holds a B.S. in Computer Science from Universidad Dominicana O&M (Dominican Republic) and an Honorary Doctorate in Quality Management Systems from Universidad Azteca (Mexico).
Ms. Ogando Roa has led global regulatory and quality programs for Class I–III devices across multinational, multi-site operations. She aligns organizations with FDA 21 CFR, ISO 13485, ISO 9001, ISO 14001, ISO 45001, MDSAP, EU MDR, KGMP, and other GxP standards. Her approach blends deep regulatory insight with practical execution, delivering scalable, cost-effective solutions that ensure long-term success in regulated markets.
Bill McGuckin
Bill has a proven track record of transforming teams and aligning top talent with organizational missions. He has spent much of his career building highly effective teams and mentoring future leaders. Prior to co-founding The Oxenham Group, Bill held leadership roles at top companies in the areas of Technology, Engineering, Compliance and Life Sciences.