Webinar

QSR to QMSR: Are you ready?

  • Date: Wednesday August 19, 2026
  • Time: 12:00 pm – 1:30 pm (NY Time)
  • Instructor(s): Rosa Fernandez
  • Webinar ID#: ECC-756
Webinar Details:

The FDA’s new Quality Management System Regulation (QMSR) represents the most significant shift in FDA quality system compliance in over 25 years. With ISO 13485:2016 becoming federal law through incorporation by reference, the medical device industry is now liable for following standards that were previously voluntary. The QMSR has been in effect since February 2, 2026, and FDA inspectors are applying it now. And the patterns showing up in audits are consistent: quality systems built for QSR compliance are not ready for QMSR scrutiny. There are several high-impact areas that manufacturers often underestimate in the transition from QSR to QMSR. Some of these include integrating risk management throughout the entire device lifecycle, a new risk- based approach to supplier management, and a greater emphasis on integrating risk management across design phases.
As part of this webinar, discussions will include regulatory drivers that led the FDA’s decision to transition from the QSR to the QMSR, key differences between the two regulations, and how the incorporation of ISO 13485:2016 affects quality management system expectations. Participants will be able to develop a practical roadmap for QMSR readiness.
Please plan to attend with a cross-functional group to gain the most from this interactive Executive Conference Corporation webinar.

Training Program Learning Benefits:

  • Explain the FDA’s transition from QSR to QMSR.
  • Identify the key differences between the QSR and the QMSR: incorporation of ISO 13485:2016 by reference
  • Assess the impact of the QMSR on the organization’s procedures and documentation.
  • Recognize common compliance gaps you may encounter during the transition.
  • Apply strategies for achieving QMSR readiness: gap assessment, remediation planning, and employee training.
  • Prepare the organization for FDA inspections.
The following should plan to attend:
  • Quality Assurance
  • Quality Control
  • Research & Development
  • Regulatory Affairs
  • Manufacturing
  • Executive management
  • Those who use contract manufacturing and contract testing facilities
  • Those who work in the Regenerative Medicine space with products that are classified as medical devices

Fee:
$385 for one person
$700 2-5 people
$999 6-10 people

Register for ECC-756