As FDA’s Quality Management System Regulation (QMSR) takes effect on February 2, 2026, medical device organizations face the most significant shift in quality and compliance expectations in decades. QMSR aligns U.S. requirements with ISO 13485:2016, embedding risk-based thinking, lifecycle oversight, and stronger quality management principles.
At the same time, the FDA’s Computer Software Assurance (CSA) guidance shifts software assurance from checklist validation to a risk-based, patient-centric model. Together, QMSR and CSA are redefining how quality, software assurance, and inspection readiness operate as a unified system.
Speakers:
🎤 Garth Conrad: Vice President, Quality, Flex Health Solutions
🎤 Francisco Vicenty (Ex-FDA): : Director, Continuous Improvement, ACT Quality & Regulatory, Getinge
🎤 Jason Dow: Principal Consultant, Compliance Group
🎤 Hillary Driscoll: IT Quality Industry Lead-Validation, Compliance Group
Moderator:
🎤 Khaled Moussally: EVP, Managing Partner, Compliance Group
Meeting date: February 26, 2026, 11:00AM to 11:45AM ET
