Sponsored Webcast: QMSR Blueprint: Complying with the FDA’s New Medical Device Regulation (On Demand)
In February 2026, the US Food and Drug Administration (FDA)’s new Quality Management System Regulation (QMSR) will overhaul medical device regulatory expectations, aligning US requirements with the international framework of ISO 13485 for the first time.
What changes are coming? How should medical device companies — inside and outside the US — prepare? And what does a new 13485-based QMSR world look like? Join us for practical insights, top tips, and a step-by-step strategy to embed lasting compliance and maximize the quality of your medical device operation.
Registration Fees & Deadlines
Member: $0 | Nonmember: $50
Learning Objectives
- Understand how the QMSR updates and alters the current requirements of FDA 21 CFR Part 820 Master the milestones to lasting QMSR compliance, including an ISO 13485 gap analysis and key regulatory differences
- Learn how to align your team around an ordered, structured transition to the new requirements
- Take full advantage of a more harmonized medical device regulatory landscape, whether you’re expanding beyond the US or moving into it
Who Should Attend?
- Quality Assurance and Quality Control Professionals
- Regulatory Affairs Specialists
- Compliance Officers
- Medical Device Manufacturers
- Process Improvement Managers
Audience Learning Level
Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.
Speakers
Sumatha Kondabolu
Vice-co-Chair RAPS Quebec LNG Senior Quality Specialist, Qualio
Sumatha has 21 years of quality and regulatory experience in the medical device and pharmaceutical sectors. She has built quality management systems for compliance with the FDA QSR, Canada’s Medical Devices Regulations, NIOSH, MDSAP, COFEPRIS, and the EU's MDR, IVDD, and IVDR. She holds a master’s in chemistry, an advanced certificate in quality assurance management, and auditor certifications for ISO 13485, ISO 17025, ISO 9001, ISO 27001, ISO 27701, and IATF 16949.
Keisha R. Thomas, MS, MHS, CQA, RAC
Associate Director for Compliance & Quality U.S. Food and Drug Administration CDRH/Office of Product Quality and Evaluation
US Food and Drug Administration
Keisha Thomas is the Associate Director for Compliance and Quality in FDA’s Center for Devices and Radiological Health. She provides strategic oversight, coordination and guidance over medical device quality, compliance, and enforcement efforts. Thomas is a coauthor of the recently published amendment to 21 CFR 820, “Quality Management System Regulation (QMSR)” — incorporating the requirements of ISO 13485:2016; and is spearheading CDRH’s implementation efforts for the proposed regulation. She has been at CDRH for 22 years and has an extensive regulatory, compliance, and enforcement background. Thomas has held multiple positions in CDRH, including Deputy Office Director for OPEQ/OHT1, Deputy Director for the Division of Premarket and Labeling Compliance, and Deputy Director for the Division of Enforcement A, and Quality System Team Lead in the former Office of Compliance, CDRH.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
