Compliance Group to Host a Live Webinar on "CSA in the Era of QMSR"

LIBERTYVILLE, Ill. - Feb. 12, 2026 - PRLog -- Illinois, Chicago, US: Compliance Group (CG) is hosting a live webinar titled "CSA in the Era of QMSR: How FDA's New Regulation Redefines Assurance Expectations," addressing a major regulatory shift for the medical device industry.

With the U.S. FDA's Quality Management System Regulation (QMSR) now LIVE and in effect, medical device manufacturers operate within a new framework that aligns quality requirements with ISO 13485:2016. The regulation introduces risk-based thinking, lifecycle oversight, and stronger quality management principles across operations.

Simultaneously, the FDA's Computer Software Assurance (CSA) guidance is shifting software assurance expectations from traditional checklist-based validation to a risk-based, patient-focused approach. Collectively, QMSR and CSA are redefining the integration of quality systems, software assurance, and inspection readiness.

What Will Attendees Learn?
The webinar will provide practical, real-world guidance on:
-How QMSR reshapes FDA expectations for quality systems and inspections
-Practical applications of CSA for production and quality system software
-Strategies to integrate CSA into the quality system
-Approaches to reduce documentation burden while maintaining inspection readiness

Speaker Panel:
-Garth Conrad, Vice President, Quality, Flex Health Solutions
-Francisco Vicenty (Ex-FDA), Director, Continuous Improvement, ACT Quality & Regulatory, Getinge
-Jason P. Dow, Principal Consultant, Compliance Group
-Hillary Driscoll, IT Quality Industry Lead, Validation, Compliance Group

Moderated by:
-Khaled Moussally, EVP & Managing Partner, Compliance Group

Who Should Attend?
The webinar is designed for Quality Assurance and QMS leaders, Regulatory Affairs and Compliance professionals, CSA and CSV practitioners, validation specialists, quality engineers, risk managers, internal auditors, inspection readiness teams, IT partners, and senior management.

Why Attend?
Compliance Group empowers your organization to interpret and apply FDA guidance effectively, providing tested models and clear steps to meeting QMSR and CSA requirements. Attend to gain clarity, confidence, and direct solutions for current regulatory demands.

Register Here: https://register.gotowebinar.com/register/9141235672409217628