PNW Chapter: FDA’s QMSR Final Rule - What Clinical Researchers Need to Know
Event Description:
An analysis of FDA’s publicly available inspection data through June 26, 2026 identified 325 medical device inspections conducted under the new Quality Management System Regulation (QMSR), resulting in 475 Form FDA 483 observations. Nearly 90% of those observations cited ISO 13485 requirements, with risk management emerging as a significant area of focus. These early findings illustrate the practical impact of QMSR across quality system processes and throughout the medical device total product lifecycle.
This webinar will examine FDA’s QMSR, what has changed for the medical device industry, and the potential downstream implications for sponsors, CROs, and research sites. We will consider what the increased emphasis on risk management means in practice and the role clinical evidence plays in informing device risk throughout the total product lifecycle.
Karin A. Hughes, Ph.D. is Principal Consultant at Hughes Regulatory & Clinical Consulting LLC and an experienced regulatory, clinical, and quality executive specializing in in vitro diagnostics, companion diagnostics, and medical devices. She is Immediate Past President and a current Board member of the Association of Medical Diagnostics Manufacturers (AMDM), where she has worked extensively on industry engagement with FDA and other regulatory stakeholders. Dr. Hughes also serves as a non-affiliated scientific board member for the Univo Institutional Review Board and holds a Ph.D. in Chemistry from the University of Virginia.
Speaker:
Karin A. Hughes, Ph.D.
Learning Objectives:
- Describe the purpose of the FDA's Quality Management System Regulation (QMSR) Final Rule and why FDA transitioned from the Quality System Regulation to QMSR.
- Discuss the direct impact of QMSR on medical device manufacturers and the resulting downstream compliance implications for sponsors, CROs, and clinical research sites.
- Explain the integrated role of risk management within QMSR and how lifecycle risk requirements connect pre-market clinical trial data to post-market safety.
- Identify practical operational challenges and questions clinical research professionals face as clinical trial stakeholders transition to the new regulation.
Registration Information:
- Chapter Member: $0
- ACRP Member: $10
- Non-Member: $20
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The educational portion of this event may be self-reported as 1 point toward an attendee’s Maintenance of Certification. These points are subject to review and acceptance by the Academy of Clinical Research Professionals in accordance with the criteria established. Attendees should keep a record of event participation in case they are randomly selected to participate in the maintenance verification process. The Chapter can provide a certificate of attendance upon request.